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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species IA (Figs. 1-2) in the reply filed on 06/01/26 is acknowledged.
Claims 4-5 & 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, Species IB-IC (Figs. 3-4), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/01/26.
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.
Claim 9 is 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.
The limitation “wherein the first fluid opening is non-detachably connectable or connected to a first end of the infusion tube or to an inlet of a drip chamber connected to the first end of the infusion tube” is failing to comply with the written description requirement. The Fig. 1 shows that the first fluid opening 12 is detachably connected to the first end of the infusion tube (via a drip chamber).
Nowhere in the original specification shows that the first fluid opening 12 being non-detachably connectable to a first end of the infusion tube 5.
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 10-13 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.
The limitation “the third coupling device and the fourth coupling device are dry-locked” is vague. The original specification does not provide a definition of “dry-locked”. Therefore, it is unclear to Examiner that what is the meaning of “dry-locked” during and after disconnected of the third coupling device from the fourth coupling device?
For example: in Fig. 1, although the third coupling device 15 is being disconnected to the fourth coupling device 9; however, the fourth coupling device 9 is in fluid connection to the infusion tube 5 (under wet condition) therefore, it cannot be called as “dry-locked”.
Claims 11-12 are being rejected due to their dependency.
In claim 13, the limitation “an infusion tube” should be changed to --- the infusion tube ---. It is noted that the limitation “infusion tube” has been introduced in the limitation “tube connector” in the claim 1.
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.
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,
wherein the tube connector 20 has a first fluid opening 64 connectable to an infusion tube (via a drip chamber 42) or a drip chamber 42 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 engage 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 being 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.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
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 on M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 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/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights