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 .
Acknowledgments
In the reply, filed on April 9, 2026, Applicant amended claims 1, 7, 9, 15, and 18-19.
Applicant cancelled claims 4, 10-11, 13-14, 16-17, 20, and 22-23.
Applicant added new claim 24.
In the non-final rejection of December 9, 2025, Examiner objected to claim 9. Applicant amended claim 9. Objection is withdrawn.
Examiner rejected claims 1-2, 4-9, and 22-23 under 35 U.S.C. 112(a). Applicant amended claim 1 and cancelled claims 22-23. Rejection is withdrawn.
Examiner rejected claims 22-23 under 35 U.S.C. 112(b). Applicant cancelled claims 22-23. Rejection is withdrawn.
Claim Objections
Claim 19 is objected to because of the following informalities:
In regards to claim 19, line 26, “the reservoir connector assembly” should be changed to “the reservoir connecting assembly”.
In regards to claim 19, line 27, “the reservoir connector assembly” should be changed to “the reservoir connecting assembly”.
In regards to claim 19, line 28, “the reservoir connector assembly” should be changed to “the reservoir connecting assembly”.
In regards to claim 19, line 29, “the reservoir connector assembly” should be changed to “the reservoir connecting assembly”.
In regards to claim 19, line 30, “the reservoir connector assembly” should be changed to “the reservoir connecting assembly”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-9, 15, 18-19, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 1, line 12 recites “the second aperture”. There is insufficient antecedent basis for this limitation in the claim. Claims 2, 5-9, 15, 18, and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 12 recites “a second aperture”. Claim 1, line 12 previously recites “the second aperture”. It is unclear whether the two recitations are the same or different. Claims 2, 5-9, 15, 18, and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 16-17 recite “the second aperture”. Claim 1, line 12 previously recites “the second aperture” and line 12 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 1, lines 16-17. Claims 2, 5-9, 15, 18, and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 21 recites “the second aperture”. Claim 1, line 12 previously recites “the second aperture” and line 12 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 1, line 21. Claims 2, 5-9, 15, 18, and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 35 recites “returning liquid”. Claim 1, line 33 previously recites “liquid”. It is unclear whether the two recitations are the same or different. Claims 2, 5-9, 15, 18, and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 6, line 2 recites “the second aperture”. Claim 6 depends upon claim 1. Claim 1, line 12 previously recites “the second aperture” and line 12 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 6, line 2.
In regards to claim 9, line 3 recites “the second aperture”. Claim 9 depends upon claim 1. Claim 1, line 12 previously recites “the second aperture” and line 12 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 9, line 3.
In regards to claim 18, line 2 recites “the second aperture”. Claim 18 depends upon claim 1. Claim 1, line 12 previously recites “the second aperture” and line 12 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 18, line 2.
In regards to claim 19, line 10 recites “the second aperture”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 19, line 11 recites “a second aperture”. Claim 19, line 10 previously recites “the second aperture”. It is unclear whether the two recitations are the same or different.
In regards to claim 19, line 13 recites “the second aperture”. Claim 19, line 10 previously recites “the second aperture” and line 11 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 19, line 13.
In regards to claim 19, line 22 recites “the second aperture”. Claim 19, line 10 previously recites “the second aperture” and line 11 previously recites “a second aperture”. It is unclear which second aperture is referred to in claim 19, line 22.
In regards to claim 19, line 28 recites “returning liquid”. Claim 19, line 26 previously recites “liquid”. It is unclear whether the two recitations are the same or different.
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 1-2, 5-7, 9, 15, 18-19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Stawski (US 3,608,550), and further in view of Yokoyama (US 3,662,752).
In regards to claim 1, Stawski teaches a reservoir connector assembly (Figures 1-2, transfer needle assembly including first cannula 21, second cannula 22, first molded part 23, and second molded part 24) for connecting to a single connection port of a fluid reservoir, the reservoir connector assembly comprising:
a first extension (21) configured to extend into the single connection port and including a first extension inner surface, a first extension outer surface, and a first extension lumen (bore 29) that is defined by the first extension inner surface, the first extension lumen including a first aperture (aperture at tip 25) that is configured to be positioned within the reservoir (Figure 2)
a second extension (22/23) configured to extend into the single connection port and including a second extension inner surface, a second extension outer surface, and a second extension lumen (bore 27/hollow interior of upstanding portion 37) that is defined by the second extension inner surface, at least a portion of the first extension lumen extending within the second extension lumen (Figure 2), the first extension lumen extending further into the reservoir than the second extension lumen (Figure 2), the first aperture positioned further into the reservoir than the second aperture (aperture at tip 28) (Figure 2), the second extension lumen including a second aperture (aperture at tip 28) that is configured to be positioned within the reservoir (Figure 2)
an outlet (outlet at tip 26) in liquid communication with the first aperture (Figures 1-2)
an inlet (inlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid) in liquid communication with the second aperture (Figures 1-2)
wherein the first extension lumen has a uniform cross-sectional area along an entire length of the first extension lumen from the first aperture to a first port (port at tip 26) (Figure 2)
wherein the second extension lumen has a variable cross-sectional area along an entire length of the second extension lumen from the second aperture to a second port (inner surface 38)
wherein the second extension is concentric around the first extension (Figure 2)
wherein the inlet is separate from the outlet (Figures 1-2)
wherein the first extension lumen is configured for liquid communication (column 4, lines 4-6: force fluid through bore 29 in cannula 21 into chamber 49 of collection container 30 until the desired amount of liquid is present therein)
Stawski does not teach wherein the second extension lumen is configured for liquid communication, as Stawski instead teaches wherein the second extension lumen is configured for air communication (column 3, lines 72-75, to column 4, line 1: air to pass through the passageway between the top of member 23 and the bottom of member 24, as represented by space 48', through the passageway 48 between ribs 45, opening 47 and finally through bore 27 of cannula 22). Yokoyama teaches a reservoir connector assembly (Figures 1-4b) wherein a first extension lumen (inner hollow portion 3) and a second extension lumen (air and liquid medicine injection groove 4) are configured for liquid communication (column 2, lines 60-63: to supply said liquid medicine into the liquid dropping cylinder 28, etc., through the liquid medicine inlet 5 and the inner hollow portion 3)(Figure 3)(column 3, lines 5-11: In the course of infusion of a liquid medicine, when it is desired to mix therein some other desired liquid medicine, the filter-attached cylindrical member 29 located in the passage 17 in the cylindrical structure 14 is removed, and instead, a suitable syringe or the like is fitted thereinto whereby to mix a desired medicine into the vial through the same route as the above-said air passage). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second extension lumen, of the assembly of Stawski, to be configured for liquid communication, as taught by Yokoyama, as such will allow for mixing some other desired liquid medicine into the liquid medicine of the reservoir in the course of infusion of the liquid medicine quickly and with extreme ease (column 3, lines 5-26).
Further, Stawski does not teach wherein the reservoir connector assembly is configured to recirculate liquid, such that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into a delivery liquid line, and returning liquid can enter the reservoir connector assembly via a return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly, as Stawski only teaches that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into a delivery liquid line (30) (Figure 2). Yokoyama teaches wherein the reservoir connector assembly is configured to recirculate liquid, such that the liquid from a fluid reservoir (column 2, line 58: vial) enters the reservoir connector assembly and passes from an outlet (12) of the reservoir connector assembly into a delivery liquid line (28) (column 2, lines 57-63), and returning liquid can enter the reservoir connector assembly via a return liquid line (column 3, line 9: syringe) and is returned to the fluid reservoir via an inlet (14) of the reservoir connector assembly (column 3, lines 5-11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified reservoir connector assembly, of Stawski and Yokoyama, to be configured to recirculate liquid, such that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into a delivery liquid line, and returning liquid can enter the reservoir connector assembly via a return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly, as taught by Yokoyama, as such will allow for desired liquid medicine to be supplied (column 2, lines 57-63) and will allow for mixing some other desired liquid medicine into the liquid medicine of the reservoir in the course of infusion of the liquid medicine quickly and with extreme ease (column 3, lines 5-26).
In regards to claim 2, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the second extension outer surface entirely surrounds the first extension lumen (Figure 2).
In regards to claim 5, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the reservoir connector assembly includes a port connector (22) having an outer surface that is configured to be received in and seal against the single connection port of the reservoir, the outer surface of the port connector being the second extension outer surface of the second extension (Figure 2).
In regards to claim 6, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first aperture is at a different elevation than the second aperture (Figure 2).
In regards to claim 7, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first aperture is at a first end of the first extension lumen and the outlet is at a second end of the first extension lumen, the first end being opposite the second end (Figures 1-2).
In regards to claim 9, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the second aperture is at a first end of the second extension and the inlet is at the second extension inner surface, further wherein the inlet extends through the second port positioned at a second end of the second extension outer surface, the first end being opposite the second end (Figures 1-2).
In regards to claim 15, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first extension terminates in a spike (25) for insertion in and penetrating a seal in the connection port, and the second extension terminates in a spike (28) for insertion in and penetrating the seal in the connection port.
In regards to claim 18, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein a cross-sectional area of the second aperture is larger than a cross-sectional area of the first aperture (Figure 2).
In regards to claim 19, Stawski teaches a method of connecting a reservoir connecting assembly (Figures 1-2, transfer needle assembly including first cannula 21, second cannula 22, first molded part 23, and second molded part 24) to a single connection port (puncturable top 35) of a fluid reservoir (fluid container 34), the reservoir connecting assembly comprising:
a first extension (21) including a first extension inner surface, a first extension outer surface, and a first extension lumen (29) that is defined by the first extension inner surface, the first extension lumen including a first aperture (aperture at tip 25) that is configured to be positioned within the reservoir (Figure 2)
a second extension (22/23) including a second extension inner surface, a second extension outer surface, and a second extension lumen (bore 27/hollow interior of upstanding portion 37) that is defined by the second extension inner surface, at least a portion of the first extension lumen extending within the second extension lumen (Figure 2), the first extension lumen extending further into the reservoir than the second extension lumen (Figure 2), the first aperture positioned further into the reservoir than the second aperture (aperture at tip 28) (Figure 2), the second extension lumen including a second aperture (aperture at tip 28) that is configured to be positioned within the reservoir (Figure 2)
an outlet (outlet at tip 26) in liquid communication with the first aperture (Figures 1-2)
an inlet (inlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid) in liquid communication with the second aperture (Figures 1-2), wherein the inlet is separate from the outlet (Figures 1-2), and the method comprising:
connecting the first extension into the single connection port (Figures 1-2)
connecting the second extension into the single connection port (Figures 1-2)
connecting a delivery liquid line (30) to the outlet of the reservoir connecting assembly (Figures 1-2)
wherein the first extension lumen has a uniform cross-sectional area along an entire length of the first extension lumen from the first aperture to a first port (port at tip 26) (Figure 2)
wherein the second extension lumen has a variable cross-sectional area along an entire length of the second extension lumen from the second aperture to a second port (38) (Figure 2)
wherein the second extension is concentric around the first extension (Figure 2)
wherein the first extension lumen is configured for liquid communication (column 4, lines 4-6: force fluid through bore 29 in cannula 21 into chamber 49 of collection container 30 until the desired amount of liquid is present therein)
Stawski does not teach connecting a return liquid line to the inlet of the reservoir connecting assembly, as Stawski instead teaches connecting air from the atmosphere to the inlet of the reservoir connecting assembly (column 3, lines 42-49). Yokoyama teaches a method comprising: connecting a delivery liquid line (liquid dropping cylinder 28) to an outlet (base 12) of a reservoir connecting assembly (Figures 1-4b) (column 2, lines 52-53: Reference number 28 designates a liquid dropping cylinder mounted between the bases 9 and 12), and connecting a return liquid line (column 2, line 36: syringe) to an inlet (cylindrical structure 14) of the reservoir connecting assembly (column 2, lines 35-37: the inner wall 16 of the cylindrical structure 14 is given a taper so as to fit with a syringe or the like.). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Stawski, with connecting a return liquid line to the inlet of the reservoir connecting assembly, as taught by Yokoyama, as such will allow for mixing some other desired liquid medicine into the liquid medicine of the reservoir in the course of infusion of the liquid medicine quickly and with extreme ease (column 3, lines 5-26).
Further, Stawski does not teach wherein the second extension lumen is configured for liquid communication, as Stawski instead teaches wherein the second extension lumen is configured for air communication (column 3, lines 72-75, to column 4, line 1: air to pass through the passageway between the top of member 23 and the bottom of member 24, as represented by space 48', through the passageway 48 between ribs 45, opening 47 and finally through bore 27 of cannula 22). Yokoyama teaches wherein a first extension lumen (3) and a second extension lumen (4) are configured for liquid communication (column 2, lines 60-63: to supply said liquid medicine into the liquid dropping cylinder 28, etc., through the liquid medicine inlet 5 and the inner hollow portion 3)(Figure 3)(column 3, lines 5-11: In the course of infusion of a liquid medicine, when it is desired to mix therein some other desired liquid medicine, the filter-attached cylindrical member 29 located in the passage 17 in the cylindrical structure 14 is removed, and instead, a suitable syringe or the like is fitted thereinto whereby to mix a desired medicine into the vial through the same route as the above-said air passage). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second extension lumen, of the modified method of Stawski and Yokoyama, to be configured for liquid communication, as taught by Yokoyama, as such will allow for mixing some other desired liquid medicine into the liquid medicine of the reservoir in the course of infusion of the liquid medicine quickly and with extreme ease (column 3, lines 5-26).
Further, Stawski does not teach wherein the reservoir connector assembly is configured to recirculate liquid, such that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into the delivery liquid line, and returning liquid can enter the reservoir connector assembly via the return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly, as Stawski only teaches that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into the delivery liquid line (Figure 2). Yokoyama teaches wherein the reservoir connector assembly is configured to recirculate liquid, such that the liquid from a fluid reservoir (column 2, line 58: vial) enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into the delivery liquid line (column 2, lines 57-63), and returning liquid can enter the reservoir connector assembly via the return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly (column 3, lines 5-11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir connector assembly, of the modified method of Stawski and Yokoyama, to be configured to recirculate liquid, such that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into the delivery liquid line, and returning liquid can enter the reservoir connector assembly via the return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly, as taught by Yokoyama, as such will allow for desired liquid medicine to be supplied (column 2, lines 57-63) and will allow for mixing some other desired liquid medicine into the liquid medicine of the reservoir in the course of infusion of the liquid medicine quickly and with extreme ease (column 3, lines 5-26).
In regards to claim 24, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the outlet comprises an outlet cross-sectional aperture area and the inlet comprises an inlet cross-sectional aperture area (Figure 2); however, while Stawski teaches that the outlet cross-sectional aperture area is less than the inlet cross-sectional aperture area (Figure 2), Stawski is silent about wherein a ratio of the outlet cross-sectional aperture area to the inlet cross-sectional aperture area is between 0.65 and 0.85. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a ratio of the outlet cross-sectional aperture area to the inlet cross-sectional aperture area, of the modified assembly of Stawski and Yokoyama, to be between 0.65 and 0.85, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified assembly of Stawski and Yokoyama would not operate differently with the claimed ratio of the outlet cross-sectional aperture area to the inlet cross-sectional aperture area. Further, Applicant places no criticality on the range claimed for the ratio of the outlet cross-sectional aperture area to the inlet cross-sectional aperture area
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Stawski and Yokoyama, as applied to claim 1 above, and further in view of Greenland (US 4,576,594).
In regards to claim 8, in the modified assembly of Stawski and Yokoyama, Stawski is silent about a drip chamber located downstream of the outlet. Yokoyama teaches a drip chamber (liquid dropping cylinder 28) located downstream of an outlet (base 12). However, Yokoyama does not disclose a motivation to combine the drip chamber with the modified assembly of Stawski and Yokoyama. Greenland teaches a reservoir connector assembly (Figures 1-4) comprising a drip chamber (drip chamber 10) located downstream of an outlet (drop former 18) (Figures 1-2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified assembly, of Stawski and Yokoyama, with a drip chamber, as taught by Greenland, as such will allow some visual indication of fluid flow such that a syringe can collect a precisely measured amount of fluid medicament to be administered to a patient (column 1, lines 37-43).
Response to Arguments
Applicant's arguments filed April 9, 2026, have been fully considered but they are not persuasive:
In regards to claims 1 and 19, Applicant argued: However, Applicant respectfully submits neither Stawski nor Yokoyama teaches or suggests a reservoir connector assembly "configured to recirculate liquid, such that the liquid from the fluid reservoir enters the reservoir connector assembly and passes from the outlet of the reservoir connector assembly into a delivery liquid line, and returning liquid can enter the reservoir connector assembly via a return liquid line and is returned to the fluid reservoir via the inlet of the reservoir connector assembly" as required by amended claims 1 and 19 (Remarks, page 7). Examiner disagrees. Yokoyama renders obvious wherein the reservoir connector assembly (Figures 1-4b) is configured to recirculate liquid, such that the liquid from a fluid reservoir (column 2, line 58: vial) enters the reservoir connector assembly and passes from an outlet (12) of the reservoir connector assembly into a delivery liquid line (28) (column 2, lines 57-63), and returning liquid can enter the reservoir connector assembly via a return liquid line (column 3, line 9: syringe) and is returned to the fluid reservoir via an inlet (14) of the reservoir connector assembly (column 3, lines 5-11).
In regards to claims 1 and 19, Applicant argued: Stawski and Yokoyama disclose one-way delivery systems, in stark contrast to the continuous two-way liquid recirculation system of the present application (Remarks, page 7). Examiner disagrees. The claims do not require “continuous two-way liquid recirculation system”, as argued by Applicant.
In regards to claims 1 and 19, Applicant argued: As such, there is no teaching or suggestion in Stawski for liquid to return back into the fluid source through either cannula 21 or 22, and the structural configuration of the transfer needle assembly is designed for single-direction filling of syringes rather than for any form of liquid recirculation as required by the amended claims. Specifically, Stawski fails to teach or suggest the air vent path having a pathway to return fluid, such as a liquid, to the fluid source. Similarly, Yokoyama discloses an infusion device where an inner bore 3 defines a one-way path of liquid medicine from a vial toward a patient, while branched cylindrical portion 11, and back-flow preventive valve 25 define a secondary path that is used intermittently to admit air into the vial or to inject an additional medicine into the vial. See Yokoyama at column 1, lines 12-28 and column 2, lines 3-37. As Yokoyama explains, the back-flow preventing valve 25 "allow[s] passage of air and liquid medicine only in the direction of injection" and prevents reverse flow from the vial back out through groove 4. Id. at column 1, lines 58-60. Thus, the secondary path is explicitly constrained to one-way flow into the vial and is not capable of, nor intended for, liquid recirculation as required by the amended claims (Remarks, page 9). Examiner disagrees. Yokoyama renders obvious wherein the reservoir connector assembly (Figures 1-4b) is configured to recirculate liquid, such that the liquid from a fluid reservoir (column 2, line 58: vial) enters the reservoir connector assembly and passes from an outlet (12) of the reservoir connector assembly into a delivery liquid line (28) (column 2, lines 57-63), and returning liquid can enter the reservoir connector assembly via a return liquid line (column 3, line 9: syringe) and is returned to the fluid reservoir via an inlet (14) of the reservoir connector assembly (column 3, lines 5-11).
In regards to claims 1 and 19, Applicant argued: Further, Applicant respectfully submits that to convert the systems of Stawski and/or Yokoyama from one-way fluid flow systems into two-way recirculation systems, would require substantial redesign of the systems. For example, the transfer needle assembly of Stawski would have to be engineered and designed for continuous liquid flow, including substantial redesign of diameters, seals, and support members to accommodate the requirements of a continuous liquid return line, and the overall system. Further, Yokoyama would need to be re-designed to permit continuous flow of liquid back into the vial, which would directly contradict the stated purpose of the back-flow preventing valve (Remarks, page 9). Examiner disagrees. The claims do not require “two-way recirculation systems”, “continuous liquid flow”, “a continuous liquid return line”, and “continuous flow of liquid”, as argued by Applicant.
In regards to claims 1 and 19, Applicant argued: This structure allows for recirculation whereby a liquid is withdrawn from the reservoir through one lumen and then returned to the same reservoir through a separate lumen. Neither Stawski nor Yokoyama, alone or in combination, discloses or suggests such a continuous recirculation structure (Remarks, pages 9-10). Examiner disagrees. The claims do not require: a liquid is withdrawn from the reservoir “through one lumen and then returned to the same reservoir through a separate lumen” and “a continuous recirculation structure”, as argued by Applicant.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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