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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 5, 2025, has been entered.
Acknowledgments
In the reply, filed on November 5, 2025, Applicant amended claims 1, 7, 10, and 19.
Applicant cancelled claim 21.
Applicant added new claims 22-23.
In the final rejection of August 5, 2025, Examiner rejected claims 19-20 under 35 U.S.C. 112(a). Applicant amended claim 19. Rejection is withdrawn.
Examiner rejected claims 19-20 under 35 U.S.C. 112(b). Applicant amended claim 19. Rejection is withdrawn.
Currently, claims 1-2, 4-11, 13-20, and 22-23 are under examination.
Claim Objections
Claim 9 is objected to because of the following informalities:
In regards to claim 9, line 2, “the liquid communication” should be changed to “liquid communication”.
In regards to claim 9, line 4, “a second port” should be changed to “the second port”.
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 1-2, 4-9, and 22-23 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.
In regards to claim 1, lines 28-30 recite: the second extension, the second extension lumen, the second aperture, the second port, “and the outlet in liquid communication with the second aperture are of monolithic construction”; however, such is new matter not described in the Specification. Claims 2 and 4-9 are rejected by virtue of being dependent upon claim 1.
In regards to claim 22, lines 4-5 recite: the second extension, the second extension lumen, the second aperture, the second port, “and the outlet in liquid communication with the second aperture are of monolithic construction”; however, such is new matter not described in the Specification.
In regards to claim 23, lines 4-5 recite: the second extension, the second extension lumen, the second aperture, the second port, “and the outlet in liquid communication with the second aperture are of monolithic construction”; however, such is new matter not described in the Specification.
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 22-23 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 22, lines 2 and 4 recite “the second port”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 22, line 5 recites: “the outlet in liquid communication with the second aperture”. Claim 22 depends upon claim 10. Claim 10, lines 13-14 recite: “an outlet in liquid communication with the first aperture; and an inlet in liquid communication with the second aperture”. When claim 10 establishes that the outlet is in liquid communication with the first aperture, it is unclear how the outlet can also be in liquid communication with the second aperture in claim 22.
In regards to claim 23, line 3 recites “the inlet”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 23, line 5 recites “the outlet”. There is insufficient antecedent basis for this limitation in the claim.
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, 4-7, 9-11, 13-20, and 22-23 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 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; or outlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid) in liquid communication with one of the first aperture and the second aperture (Figures 1-2)
an inlet (inlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid; or inlet at tip 26) in liquid communication with the other of the first aperture and 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 either: the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of monolithic construction, or the second extension, the second extension lumen, the second aperture, the second port, and the outlet in liquid communication with the second aperture are of monolithic construction, as Stawski instead teaches the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified assembly of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
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 4, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first extension lumen is concentric with the second 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 an output aperture (aperture at tip 25) and the outlet (outlet at tip 26) is in liquid communication with the first aperture, and 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 an inlet aperture (aperture at tip 28) and the inlet (inlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid) is in the liquid communication with the second aperture, and 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 a second port (inner surface 38) 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 10, 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 connection port of a fluid reservoir, the reservoir connector assembly comprising:
a first extension (21) configured to extend into the connection port and into the reservoir, the first extension 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) configured to extend into the connection port, the second extension including a second extension inner surface, a second extension outer surface, and a second extension lumen (27) that is defined by the second extension inner surface, the second extension lumen including a second aperture (aperture at tip 28) that is configured to be positioned within the reservoir, 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 (Figure 2)
an outlet (outlet at tip 26) in liquid communication with the first aperture
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
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 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 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).
In regards to claim 11, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein at least a portion of the first extension lumen extends within the second extension lumen (Figure 2).
In regards to claim 13, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first extension lumen is concentric with the second extension lumen (Figure 2).
In regards to claim 14, 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 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 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 16, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the first aperture is an output aperture (aperture at tip 25) and the outlet is in liquid communication with the first aperture, and 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 17, in the modified assembly of Stawski and Yokoyama, Stawski teaches wherein the second aperture is an inlet aperture (aperture at tip 28) and the inlet is in liquid communication with the second aperture (inlet at end of second cannula 22 opposite to tip 28, which is structurally capable of receiving liquid), and wherein the second aperture is at a first end of the second extension lumen and the inlet is at the second extension inner surface, further wherein the inlet extends through a second port (38) 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 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 second extension lumen including a second aperture (aperture at tip 28) that is configured to be positioned within the reservoir (Figure 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)
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 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 method comprising 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 method 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).
In regards to claim 20, in the modified method of Stawski and Yokoyama, Stawski teaches connecting a delivery liquid line (collection container 30) to an outlet (outlet at tip 26) of the reservoir connecting assembly (Figures 1-2); however, Stawski does not teach connecting a return liquid line to an inlet of the reservoir connecting assembly, as Stawski instead teaches connecting air from the atmosphere to an inlet (inlet at end of second cannula 22 opposite to tip 28) of the reservoir connecting assembly (column 3, lines 42-49). Yokoyama teaches 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 modified method, of Stawski and Yokoyama, with connecting a return liquid line to an 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).
In regards to claim 22, in the modified assembly of Stawski and Yokoyama, Stawski does not teach wherein either: the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of monolithic construction, or the second extension, the second extension lumen, the second aperture, the second port, and the outlet in liquid communication with the second aperture are of monolithic construction, as Stawski instead teaches the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified assembly of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
In regards to claim 23, in the modified method of Stawski and Yokoyama, Stawski does not teach wherein either: the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of monolithic construction, or the second extension, the second extension lumen, the second aperture, the second port, and the outlet in liquid communication with the second aperture are of monolithic construction, as Stawski instead teaches the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified method of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
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 November 5, 2025, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: First, to contend that cannula 22 of Stawski is functioning as an inlet for liquid while tip 26 is functioning as an outlet (or vice versa) would require a fundamental change in the way the Stawski syringe operates. In the configuration as disclosed in Stawski, cannula 21 is designed to be inserted into a liquid vial and liquid is drawn into the syringe container when the plunger is retracted. See Stawski at column 3, lines 35-38 and column 4, lines 1-6. Cannula 22, by contrast, is specifically configured and positioned to act as an air vent that admits atmospheric air into the interior of the syringe container. See Id. at column 3, lines 38-49. The air entering through cannula 22 equalizes the pressure inside the syringe, thereby preventing the formation of a vacuum as fluid is withdrawn through cannula 21 and tip 26 into the syringe body. See Id. at column 3, line 72-column 4, line 6. Thus, each cannula has a distinct function: cannula 21 is responsible for liquid transfer, while cannula 22 solely provides a path for air ingress. See FIG. 2 of Stawski below. Applicant submits that if cannula 22 and tip 21 are both utilized for liquid communication the original pressure equalization function of the syringe would be disrupted, and operation of the syringe would be adversely affected. To overcome this, a complete redesign of the syringe would be required and such modifications would change the basic operating principle of Stawski's device, which relies on dedicated and separate flow paths for atmospheric air and for liquid, and would not achieve the same functional outcome as originally intended (Remarks, pages 9-11). Examiner disagrees. Yokoyama, like Stawski, discloses that air pressure can be delivered to an inlet (14) and then to a second extension lumen (4) and then to a vial (column 2, lines 63-66: air is injected into said vial through the flow passage hole 17, back-flow preventive valve 25 and air and liquid medicine injection groove 4 to generate a positive pressure in said vial) and further discloses that liquid pressure can similarly be delivered to the inlet and then to the second extension lumen and then to the vial (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). Thus, Yokoyama shows that either air or liquid positive pressure can be delivered to the vial in order to equalize pressure while liquid from the vial is withdrawn through the first extension lumen (3), and thus arrives at the same end result of Stawski with air positive pressure. Thus, in the combination of Stawski and Yokoyama, 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).
In regards to claim 1, Applicant argued: Second, claim 1 requires that both the inlet and outlet be in liquid communication with respective apertures of the extensions, whereas in Stawski, cannula 22 is not designed or configured to place liquid in communication with the syringe container; it is only constructed for introduction of atmospheric air. Thus, the use and configuration of the cannulas in Stawski is fundamentally different from claim 1 (Remarks, page 11). Examiner disagrees. In Stawski, the inlet (inlet at end of second cannula 22 opposite to tip 28) is structurally capable of receiving liquid, and is thus capable of being in liquid communication with the second aperture (aperture at tip 28) (Figures 1-2).
In regards to claim 1, Applicant argued: Lastly, Applicant submits that regardless of whether the cannula 22 or tip 21 is considered the inlet, Stawski fails to teach or suggest the second extension, the second extension lumen, the second aperture, the second port, and either the inlet or the outlet being of monolithic construction as required in claim 1 (Remarks, page 11). Examiner agrees that Stawski instead teaches the second extension (22/23), the second extension lumen (bore 27/hollow interior of upstanding portion 37), the second aperture (aperture at tip 28), the second port (38), and the inlet (inlet at end of second cannula 22 opposite to tip 28) in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified assembly of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
In regards to claims 10 and 19, Applicant argued: Independent claims 10 and 19 have been amended to require "wherein the first extension lumen and the second extension lumen are configured for liquid communication." For the reasons discussed above regarding the change in principle of operation of Stawski, Applicant submits claims 10 and 19 are patentable over Stawski. Because claims 11 and 13-18 depend from claim 10, Applicant submits claims 11 and 13-18 are also patentable. Applicant respectfully requests that this rejection be withdrawn (Remarks, page 11). Examiner disagrees for the same reasons as provided above with respect to claim 1.
In regards to claim 22, Applicant argued: Claim 22 requires "wherein either: the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of monolithic construction, or the second extension, the second extension lumen, the second aperture, the second port, and the outlet in liquid communication with the second aperture are of monolithic construction." Applicant submits Stawski, Greenland, and Yokoyama fail to teach or suggest these limitations (Remarks, page 12). Examiner agrees that Stawski instead teaches the second extension (22), the second extension lumen (27), the second aperture (aperture at tip 28), the second port (38), and the inlet (inlet at end of second cannula 22 opposite to tip 28) in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified assembly of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
In regards to claim 23, Applicant argued: Claim 23 requires "wherein either: the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture are of monolithic construction, or the second extension, the second extension lumen, the second aperture, the second port, and the outlet in liquid communication with the second aperture are of monolithic construction." Applicant submits Stawski, Greenland, and Yokoyama fail to teach or suggest these limitations (Remarks, page 12). Examiner agrees that Stawski instead teaches the second extension (22/23), the second extension lumen (bore 27/hollow interior of upstanding portion 37), the second aperture (aperture at tip 28), the second port (38), and the inlet (inlet at end of second cannula 22 opposite to tip 28) in liquid communication with the second aperture are of two-piece construction (Figures 1-2). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture, of the modified method of Stawski and Yokoyama, to be of monolithic construction, as Applicant has not disclosed that such a construction provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the second extension, the second extension lumen, the second aperture, the second port, and the inlet in liquid communication with the second aperture being of two-piece construction, as taught by Stawski, as a person having ordinary skill in the art would have expected either construction to provide for the same end result of communication of liquid or air therethrough.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783