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 (claims 1-12) in the reply filed on 12/18/25 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/25.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a mixing lumen”; “a proximal end of the mixing lumen” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6-12 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.
The limitation “the mixing lumen is in a connector comprising a first asymmetric coupler positioned on a proximal end of the connector” is failing to comply with the written description requirement. As shown in Fig. 2, the mixing lumen is located inside and at distal portion 115a of the connector 115; however, a first coupler 122 is not an asymmetric coupler. The coupler 192a/192b is as a first asymmetric coupler; however, the mixing lumen is not located in the connector 192; wherein the asymmetric coupler 192 is located on a distal end of the connector, but not on a proximal end of the connector, as required in the claim 6. Similarly, the connector 132 is an asymmetric coupler. The mixing lumen (of the syringe adapter 120) is not located in the connector 132; wherein asymmetric coupler 132a/b is located at distal end of the connector 132 but not located at proximal end of the connector, as required in the claim 6.
Claims 7-12 are being 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 3-4 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 claims 2-12 are being rejected due to their dependency.
In claim 3, the term “a second plunger rod” is defined in claim 3 without a first plunger rod being defined previously, rendering the claim unclear.
In claim 4, the term “a third state” is defined in claim 4 without a second state being defined previously, rending the claim unclear.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melanson et al. (US 6,610,033).
Regarding claim 1, Melanson discloses a system in Figs. 1-3B for producing a mixture to deliver to a treatment site, comprising:
a mixing lumen (e.g., lumens 21 & 22 are merged in a mixing lumen at distal end portion of a connector/adapter 20, wherein the mixing lumen is being connected to a connector 29, in Fig. 2A. Note: for convenience, the mixing lumen is temporary label #20 for the mixing lumen 20) attachable to a proximal end 28 of a delivery system 18, see Fig. 2A;
a multi-lumen chamber (including syringes 12 & 14) removably connected to a proximal end 26 & 27 of the mixing lumen 20, the multi-lumen chamber comprising a first lumen 12 aligned with a second lumen 14;
the first lumen 12 configured to comprise a first constituent in a first state (initial state or before mixing state), the first lumen 12 comprising a first plunger (a stopper located inside the syringe 12) to move the first constituent from the first lumen to the mixing lumen, and the first lumen 12 terminating in a first port 60, see Fig. 2A;
the second lumen 14 configured to comprise a second constituent, the second lumen 14 comprising a second plunger (a stopper located inside the syringe 14) to distally move the second constituent, and the second lumen 14 terminating in a second port 62, see Fig. 2A; and
a vial adaptor 11 (Fig. 1) comprising a vial 15/16 with a third constituent, the vial adaptor 11 configured to connect to the multi-lumen chamber 12 & 14, see Fig. 1.
Regarding claim 2, wherein the first and second lumens 12 & 14 are adjacent each other.
Regarding claim 3, the second lumen 14 comprising a second plunger rod (a plunger rod on the right side and located inside the second lumen 14 and connected to the actuator 17, see Fig. 2A) internally positioned therein to distally move the second constituent and the first constituent. Note: when the actuator 17 is advanced, the first and second liquid in syringes 12 & 14 are introduced into the vials 15 & 16, col. 5, lines 60-63.
Regarding claim 4, wherein in a third state (when the fluids of the syringes 12 & 14 flow into the mixing lumen 20), distally moving the second plunger rod causes a first mixture and the second constituent (in the second syringe 14) to be delivered through the first and second ports, mixed together within the mixing lumen to form the mixture, and delivered through the delivery system.
Regarding claim 5, wherein in a second state, proximally moving a first plunger rod of the first lumen 12 causes a first mixture to be transported from the vial 15 to the first lumen 12 (e.g., the syringe 12 is pre-filled with a first liquid, which when mixed with a substantially dry powder in vial 15, forms a first component (or first mixture), col. 5, lines 44-47).
Regarding claim 6, wherein in wherein the mixing lumen (at distal end portion 20) is in a connector/adaptor 20 comprising a first asymmetric coupler 26/27 positioned on a proximal end of the connector 20, see marked-up Fig. 2A.
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Regarding claim 7, wherein the multi-lumen chamber comprises a second asymmetric coupler 60/62 (in Fig. 2A) or 2/4 (in Fig. 1) positioned on a distal end of the multi-lumen chamber and configured to removably connect to the first asymmetric coupler 26/27, see Figs. 1-2A.
Regarding claim 8, wherein the vial adaptor 11 comprises an asymmetric coupler 6/8 comprising an outer profile substantially similar to the first asymmetric coupler 26/27 so as to removably connect with the second asymmetric coupler 2/4 (in Fig. 1) or 60/62 (in Fig. 2A).
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Regarding claim 9, wherein in the first state, the second asymmetric coupler 2/4 is connected with the asymmetric coupler 6/8 of the vial adaptor so that distally moving a first plunger rod of the first lumen causes the first constituent to be delivered through the first port into the vial to form a first mixture, col. 5, lines 5-26.
Regarding claim 10, wherein the vial adaptor 11 further comprises a first fluid port (of the vial adaptor 11) to removably connect with the first port (at the connector 2 of the syringe 12) and a second alignment port (of the vial adapter 11) to removably connect with the second port (at the connector 4 of the syringe 14), the first fluid port and the second alignment port being surrounding by the outer profile of the asymmetric coupler, see the marked-up Fig. 1 in the rejection of claim 8 above.
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.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Melanson et al. (US 6,610,033) in view of Reed et al. (US 2010/0063460).
Regarding claims 11-12, Melanson discloses all the claimed subject matter as required. Melanson further discloses the vial adaptor 11 comprising: a tube/passage between the vial 15 and the first fluid port (of the vial adapter 11). Melanson does not disclose the limitation that a vent for venting air in the tube, the vial, and the first fluid port, the vent being positioned between the vial and the first fluid port.
Reed discloses a vial adaptor system in Figs. 1 & 4-5 comprising: a vial 10; a tube 114 or (114 & 110) between the vial 10 and a first fluid port 152; a vent 136 for venting air in the tube 114, the vial 10, and the first fluid port 152, the vent 136 (and/or passage 146, 148) being positioned between the vial 10 and the first fluid port; wherein the tube 114 comprises one or more approximately perpendicular bends (at 144) distal of the vial 10 and proximal of the first fluid port 152; and wherein the vent 136/146/148 is positioned proximal or adjacent the one or more approximately perpendicular bends, see Figs. 1 & 4.
Alternatively, the Fig. 4 shows that a tube 218 & 240 between the vial and the first fluid port 252; a vent 236/246/250 for venting air in the tube, the vial and the first fluid port, the vent being positioned in between the vial and the first fluid port; wherein the tube 218 & 240 comprises one or more approximately perpendicular bends (near #244 in Fig. 5) distal of the vial 10 and proximal of the first fluid port 252; and wherein the vent 236/246/250 is positioned proximal or adjacent the one or more approximately perpendicular bends (near #244 in Fig. 5).
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 vial adaptor or vial of Melanson with providing a tube being located in between the vial and the fluid port; and including a vent, as taught by Reed, in order to allow gas into the container to replace the void volumes created as the fluid is withdrawn from the vial.
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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.
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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