DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 09/14/26 has been entered in the case. Claims 1-3, 6-13 are pending for examination and claims 4-5 & 14-15 are withdrawn.
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 1-3 and 6-13 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 claim 1, the limitation “... a first fluid opening alternatively directly connectable to an infusion tube or a drip chamber connected to an infusion tube...” is failing to comply with the written description requirement.
The elected Figs. 1-2 show that the first fluid opening 12 is not directly connectable to an infusion tube 5.
Applicant states on page 6 of the Remarks 09/14/26 that the first coupling device 13 and the second coupling device 8 may form a “non-detachable connection”. Applicant further states that the Specification states that the drip chamber 4 is not required.
Regardless, if the drip chamber 4 is not included in the system and the first coupling device 13 and the second coupling device 8 form a non-detachable connection, then the first coupling device 13 (or the first fluid opening 12) is not directly connectable to the infusion tube 5. In other words, the first coupling device 13 or the first fluid opening 12 is indirectly connectable to the infusion tube 5 via the second coupling device 8. See the marked-up figure below.
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For example: if the second coupling device 8 is optional or omitted, then the first coupling device 13 can be directly connected to the infusion tube 5.
If the drip chamber 4 is included in the system; and the first coupling device 13 (or the first fluid opening 12) and the second coupling device 8 may form a “non-detachable connection”. In this case, the first coupling device 13 (or the first fluid opening 12) is not directly connectable to the infusion 5. In other words, the first coupling device 13 or the first fluid opening 12 is indirectly connectable to the infusion tube 5 via the second coupling device 8 and the drip chamber 4. See Fig. 1 in the original filed.
The other claims 2-3 & 6-13 are rejected due to their dependency.
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 1-3 and 6-13 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 claim 1, the limitation “a first fluid opening alternatively directly connectable to an infusion tube or a drip chamber connected to an infusion tube...” is vague.
The limitation above can be understood in two different ways: (1) the first fluid opening 12 connects directly to an infusion tube 5; or (2) the first fluid opening 12 connects to a drip chamber 4, which is already attached to an infusion tube. Therefore, it is unclear to the Examiner which direction the claimed invention is directed toward.
The other claims 2-3 & 6-13 are rejected due to their dependency.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1st set of rejection
Claims 1-3, 6-7, 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al. (US 2011/0275988).
Regarding claims 1-2, Davis discloses a tube connector 20 for an infusion tube,
wherein the tube connector 20 is connectable or connected to an infusion container 12,
with regarding to the limitation “... a first fluid opening alternatively directly connectable to an infusion tube or a drip chamber connected to an infusion tube... “, it can be understood in two different ways: (1) the first fluid opening connects directly to an infusion tube; or (2) the first fluid opening connects to a drip chamber, which is already attached to an infusion tube.
For examination purposes, the examiner interprets this according to the second option (e.g., the first fluid opening connects to a drip chamber). In this case, Fig. 12 clearly shows that the first fluid opening 64 is directly connectable to a drip chamber 42, which is connected to an infusion tube 50 to provide a first fluid connection between the infusion container 12 and the infusion tube 50.
wherein the tube connector 20 has a second fluid opening 34 connectable to the infusion tube 50 to provide a second fluid connection between the infusion container 12 and the infusion tube 50, see Fig. 12, and
wherein the tube connector 20 comprises a blocking device (e.g., slit/check-valve 84), which is configured to block the second fluid opening against a release of fluid from the tube connector.
Note: In Fig. 12, the valve 84 allows a fluid from the infusion tube 50 to the connector 20 but prevents the fluid from the container 12 into the infusion tube 50. Therefore, the valve 84 is equivalent to a blocking device or one-way valve (check valve).
Regarding claim 3, wherein the tube connector 20 has a connecting structure (a flange structure being engaged to a septum 36 of the container 12) with which the tube connector 20 is connectable to the infusion container 12.
Regarding claim 6, Davis discloses all claimed subject matter as required. Davis further discloses that wherein the tube connector 20 has, in a region of the first fluid opening 64, a first coupling device (at proximal region of the tube connector 20 being connected to a distal portion of a drip chamber 40) which is connectable to a second coupling device, which is complementary to the first coupling device and attached to a first end of the infusion tube 50 (via a drip chamber 40) or to an inlet (a passage of the second coupling device) of the drip chamber 40 connected to the first end of the infusion tube 50, in order to provide the first fluid connection between the infusion container 12 and the infusion tube 50.
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Regarding claim 7, wherein the first coupling device and the second coupling device provide a needle-based coupling (e.g., the connector 20 is spike and considered as a needle; wherein the first and second coupling devices are supporting the spike/needle. Therefore, the first and second coupling devices are called as needle-based coupling).
Regarding claim 9, as best as understood, wherein the first fluid opening 64 is non-detachably connectable or connected to a first end of the infusion tube 20 or to an inlet of a drip chamber 40 connected to the first end of the infusion tube 50, see Fig. 12.
Regarding claim 10, wherein the tube connector 20 has, in a region of the second fluid opening 34, a third coupling device 26 which is connectable to a fourth coupling device 56, which is complementary to the third coupling device 26 and attached to a second end of the infusion tube 58, in order to provide the second fluid connection between the infusion container 12 and the infusion tube 50, see Fig. 12,
wherein a connection between the third coupling device 26 and the fourth coupling device 56 is a releasable connection, and wherein the third coupling device and the fourth coupling device are dry-locked (e.g., as best as understood, no fluid connection in between the third and fourth coupling devices, as shown in Fig. 1A) during and after disconnection of the third coupling device 26 and from the fourth coupling device 56.
Regarding claim 11, wherein the third coupling device 26 and the fourth coupling device 56 provide a needle- based coupling (Note: the third coupling device 56 is in form as a needle; and the fourth coupling device 26 can be hold a needle, therefore, both of the third and fourth coupling devices 26 & 56 can be called as a needle-based coupling).
Regarding claim 12, wherein the third coupling device 26 and the fourth coupling device 56 have a locking structure (at slit 84) for locking a connection between the third coupling device and the fourth coupling device, see Fig. 12.
Regarding claim 13, Davis discloses an infusion set comprising; a tube connector 20 (as being analysis in the claim 1 above); and an infusion tube 50,
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2011/0275988) in view of Larson et al. (US 2018/0250055).
Regarding claim 8, Davis discloses all claimed subject matter as required except for the limitation that wherein the first coupling device and the second coupling device comprise a locking structure for locking a connection between the first coupling device and the second coupling device.
Note: the first and second coupling devices in Davis are unitary unit. Meanwhile, the claimed invention requires the first and second coupling device are being two separate units via a locking structure. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the first and second coupling device are two separate units, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Larson discloses a tube connector 102 is connected to an infusion container 200; a first coupling device (see the marked-up Fig. 4A below) which is connectable to a second coupling device 301, which is complementary to the first coupling device; wherein the first coupling device and the second coupling device comprise a locking structure (a connection in between the first and second coupling devices, see Fig. 2) for locking connection between the first coupling device and the second coupling device.
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Davis with obtaining the first and second coupling device are being separated unit and being attached via a locking structure, as taught by Larson, in order to provide a tube connector and a drip chamber being separated units for easy assembling and handling before and after use.
2nd set of rejection
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Wallen et al. (US 2003/0191445) in view of Davis et al. (US 2011/0275988).
Regarding claim 1, Wallen discloses a tube connector 100 for an infusion tube,
wherein the tube connector 100 (in combination of first portion 107 and second portion 108) is connectable to an infusion container 120,
with regarding to the limitation “... a first fluid opening alternatively directly connectable to an infusion tube or a drip chamber connected to an infusion tube... “, it can be understood in two different ways: (1) the first fluid opening connects directly to an infusion tube; or (2) the first fluid opening connects to a drip chamber, which is already attached to an infusion tube.
For examination purposes, the examiner interprets this according to the first option (e.g., the first fluid opening connects directly to an infusion tube). In this case, Fig. 4 clearly shows that the first fluid opening 103 is directly connectable to an infusion tube 215 to provide a first fluid connection between the infusion container 120 and the infusion tube 215.
Note: a piercing member 214 is a part of the infusion tube 215, see para [0052].
wherein the tube connector 100 has a second fluid opening 102; and
wherein the tube connector 100 comprises a blocking device 106 configured to block the second fluid opening 102 against a release of fluid from the tube connector 100.
Wallen does not disclose that the second fluid opening is connectable to the infusion tube to provide a second fluid connection between the infusion container and the infusion tube.
Davis discloses a tube connector 20 for an infusion tube 50; wherein the tube connector 20 is connectable or connected to an infusion container 12; the tube connector has a second fluid opening 26 connectable to the infusion tube 50 to provide a second fluid connection between the infusion container 12 and the infusion tube 50.
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 system of Wallen by providing a second fluid opening connected to an infusion tube to provide a second fluid connection between the infusion container and the infusion tube, as taught by Davis, in order to purge air and gases into the infusion container.
Regarding claim 2, Wallen in view of Davis discloses all the claimed subject matter as required. Wallen discloses that the blocking device is a blocking membrane 106. Meanwhile, the claimed invention requires that blocking device is as a check valve.
Davis discloses that the tube connector 12 comprises a block device 84 allows a fluid from the infusion tube 50 to the connector 20 but prevents the fluid from the container 12 into the infusion tube 50. Therefore, the valve 84 is equivalent to a blocking device or one-way valve (check valve).
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 or replace the blocking device of Wallen in view of Davis by providing a check valve, as taught by Davis, in order to enhance sealing and prevent fluid from leaking out from the container into the infusion tube.
Regarding claim 3, Wallen in view of Davis discloses all the claimed subject matter as required. Wallen discloses that the tube connector 100 has a connecting structure (spike portion of the first portion 107) with which the tube connector 100 is connectable to the infusion container 120.
Regarding claim 6, Wallen in view of Davis discloses all the claimed subject matter as required. Wallen discloses that wherein the tube connector 100 has, in region 108 of the first fluid opening 103,
a first coupling device 108 which is connectable to a second coupling device 107, which is complementary to the first coupling device 108 and attached to a first end 214 of the infusion tube in order to provide the first fluid connection between the infusion container and the infusion tube.
Note: the limitation follows conjunction “or”, e.g., or to an inlet of the drip chamber connected to the first end of the infusion tube, is optional to include the device system. Since the prior art of Wallen shows the first option, as mentioned above. Additionally, Davis discloses that an inlet of the drip chamber is connected to the first end of the infusion tube. One ordinary skill in the art would recognize that the Wallen device can be modified to include the drip chamber of Davis in order to trap gas and air bubbles and monitor the fluid flow into a patient.
Regarding claim 7, Wallen discloses that wherein the first coupling device 108 and the second coupling device 107 provide a needle-based coupling, see Fig. 4.
Regarding claim 8, Wallen discloses that wherein the first coupling device and the second coupling device comprise a locking structure 111/112 for locking a connection between the first coupling device and the second coupling device.
Regarding claim 9, Wallen discloses wherein the first fluid opening 103 is connected to a first end of the infusion tube
Additionally, Davis discloses that the first fluid opening 64 is connected to an inlet 62 of a drip chamber connected to the first end 48 of the infusion tube 50.
Regarding claim 10, Wallen discloses that wherein the tube connector has, in a region 107 of the second fluid opening 102. Davis discloses that wherein the tube connector 20 has, in a region of the second fluid opening 34, a third coupling device 26 which is connectable to a fourth coupling device 56, which is complementary to the third coupling device 26 and attached to a second end of the infusion tube 58, in order to provide the second fluid connection between the infusion container 12 and the infusion tube 50, see Fig. 12, wherein a connection between the third coupling device 26 and the fourth coupling device 56 is a releasable connection, and wherein the third coupling device and the fourth coupling device are dry-locked (e.g., as best as understood, no fluid connection in between the third and fourth coupling devices, as shown in Fig. 1A) during and after disconnection of the third coupling device 26 and from the fourth coupling device 56.
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 Wallen in view of Davis by providing a third coupling device being connected to a fourth coupling device, as taught by Davis, in order to enhance sealing and prevent fluid from leaking out from the infusion tube into the infusion container.
Regarding claim 11, Wallen in view of Davis discloses all the claimed subject matter as required. Davis discloses that wherein the third coupling device 26 and the fourth coupling device 56 provide a needle- based coupling (Note: the third coupling device 56 is in form as a needle; and the fourth coupling device 26 can be hold a needle, therefore, both of the third and fourth coupling devices 26 & 56 can be called as a needle-based coupling).
Regarding claim 12, Wallen in view of Davis discloses all the claimed subject matter as required. Davis discloses that wherein the third coupling device 26 and the fourth coupling device 56 have a locking structure (at slit 84) for locking a connection between the third coupling device and the fourth coupling device, see Fig. 12.
Regarding claim 13, Wallen (or Wallen in view of Davis) discloses an infusion set comprising the tube connector (as being analysis in the claim 1 above); and the infusion tube 215.
Response to Arguments
Applicants’ arguments filed 09/14/26 have been fully considered but they are not persuasive.
1) Applicant argues that Davis teaches an infusion set connector that is integrally formed with a drip chamber and includes a secondary inlet that can connect to the end of the infusion tube. Davis does not teach or suggest that the connector has a first out that can connect directly to an infusion tube, as recited in claim 1.
In response, the limitation above involves 112, 2nd paragraph issue, as discussed above. The limitation above can be understood in two different ways: (1) the first fluid opening connects directly to an infusion tube; or (2) the first fluid opening connects to a drip chamber, which is already attached to an infusion tube. For examination purposes, the examiner interprets this according to the second option (e.g., the first fluid opening connects to a drip chamber). In this case, Fig. 12 clearly shows that the first fluid opening 64 is directly connectable to a drip chamber 42, which is connected to an infusion tube 50 to provide a first fluid connection between the infusion container 12 and the infusion tube 50.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
