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 .
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 “the outer peripheral surface is substantially orthogonal to a contact surface of the valve body”, as claimed in claim 4, 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 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.
Claim 4 is 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 term “substantially” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 4 further recites the limitation of “the outer peripheral surface is substantially orthogonal to a contact surface of the valve body” which is not clear what meant by being “orthogonal” since those two parts (outer peripheral surface and valve body) are appear to be IN LINE rather than “orthogonal”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Griggs (WO2012151542A2 the US equivalent of US20130123619A1 cited below) in view of Py (US 20100276035 A1).
Regarding claim 1, Griggs teaches a liquid medicine administration device comprising;
a needle unit configured to be inserted into and placed on a living body (“medical fluid injection systems” [0002]; “a plunger within the syringe assembly 80A” [0040]);
a liquid medicine supply device (80a) provided separately from the needle unit and configured to deliver a liquid medicine filled inside from a distal portion (see fig. 2A and the associated pars.),
a tube (102) configured to allow the liquid medicine to flow, the tube having a distal end connected to the needle unit (“the plunger injects liquid into the patient line (e.g., patient line 102 in FIG. 1C). For example, when a plunger within the syringe assembly 80A moves in a forward direction (to the left in FIG. 1B), the plunger is capable of injecting liquid into the output tubing 100A. When moving in a rearward direction (to the right in FIG. 1B), the plunger is capable of filling liquid into the syringe assembly 80A” [0040]), and
a connector (104) a connector to which the liquid medicine supply device is attached, the connector being located at a proximal end of the tube (see e.g., fig. 1C and the associated pars.), wherein the connector comprises;
a valve body (260) that has a disk shape and that opens during delivery of the liquid medicine to allow the liquid medicine supply device to communicate with the tube (“FIG. 3, contrast media inlet port 240 is tapered outward (in the forward flow direction, i.e., from right to left in FIG. 3) to create a pocket 245 in front of an elastomeric disc 260 so that as fluid travels through the contrast media inlet port 240 and into the empty pocket, air is forced from the pocket (purged) through the disc slit 270 and into the valve body 220 (more precisely, into the cavity in the valve body which is adapted to fluid flow). Thus, for example, in an angiographic procedure, as contrast media fills the empty pocket 245 of the disc holder 255 and pressure builds, the elastomeric valve disc 260 bends and eventually opens the slit 270” [0058]), and
a valve seat that is provided on a tube side with respect to the valve body, the valve seat protruding toward the valve body so that the valve body contacts the valve seat (see fig. 3 and the associated pars.) wherein;
the valve body has an opening/closing hole that has a slit shape and that passes through the valve body in an axial direction at a central part (270); and
the valve seat has an inclined portion inclined radially inward toward the tube (see e.g., (280) as seen in fig. 3 and the associated pars).
Although, it is a common knowledge that is within the skilled artisan and it is also an obvious design choice to have a valve seat that is annular, in an effort to provide compact prosecution, Py has been introduced to show the teaching of valve seat that is annular as shown in detail below.
In the same field of endeavor, Py teaches to create a hermetically-sealed compartment for storage of the preparation in the syringe, compartment(s) for storage of the preparation is filled by inserting a needle through the fusible stopper into the storage compartment. As the storage compartment is filled, the air in the storage compartment is allowed to escape through an annular one-way valve formed on the outer periphery of the fusible stopper [0016]. The peripheral wall 28, an annular raised portion or protuberance 34 dimensioned to be frictionally received within the chamber 18 of the syringe body 12 further seals the plunger assembly 14 and prevents air from contacting the medicament contained within the syringe. At the top of the peripheral wall 28, a one-way valve is formed by a wedge-shaped, flexible annular flap 36, which is shaped and dimensioned to be flexible and to contact the inside of the syringe body 12 to form the annular one-way valve [0038] also see fig. 2 and the associated pars.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with valve seat that is annular as taught by Py because to provide a syringe that can be filled with a sterile substance, such as a vaccine, medicament or other pharmaceutical preparation, while maintaining the sterility of the syringe and substance during filling and storage thereafter ([0006] of Py).
Regarding claim 2, Griggs teaches the valve seat is located at a position on a radially outer side with respect to the opening/closing hole, and has a valve seat surface that the valve body contacts, an inner peripheral surface located on an opening/closing hole side with respect to the valve seat surface, and an outer peripheral surface located on a side opposite to the opening/closing hole with respect to the valve seat surface, and the inclined portion is formed on the inner peripheral surface (see exemplary re-produced fig. 3 below, along with fig. 4 and the associated pars.).
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Regarding claim 3, Griggs teaches wherein the valve body is formed of an elastic material, and has a shape in which a dimension in an axial direction of the connector is smaller than a dimension in a radial direction of the connector (“fluid delivery valve 104 comprises an elastomeric valve assembly… the elastomeric valve disc 260 bends” [0058]).
Regarding claim 4 (as the claim best understood in light of the 35 USC 112 rejections above), Griggs teaches wherein the outer peripheral surface is substantially orthogonal to a contact surface of the valve body that contacts the valve seat (see exemplary re-produced fig. 3 above, along with fig. 4 and the associated pars.)
Regarding claim 5, Griggs teaches wherein the connector has a surface that faces a valve seat surface of the valve seat and with which the valve body comes in contact, and the valve body is held between the surface and the valve seat (see exemplary re-produced fig. 3 above, along with fig. 4 and the associated pars.).
Regarding claim 7, Griggs teaches a liquid medicine administration device comprising;
a needle unit configured to be inserted into and placed on a living body (“medical fluid injection systems” [0002]; “a plunger within the syringe assembly 80A” [0040]);
a tube (102) configured to allow a liquid medicine to flow, the tube having a distal end connected to the needle unit (“the plunger injects liquid into the patient line (e.g., patient line 102 in FIG. 1C). For example, when a plunger within the syringe assembly 80A moves in a forward direction (to the left in FIG. 1B), the plunger is capable of injecting liquid into the output tubing 100A. When moving in a rearward direction (to the right in FIG. 1B), the plunger is capable of filling liquid into the syringe assembly 80A” [0040]), and
a connector (104) configured to be connected to a liquid medicine supply device, the connector being located at a proximal end of the tube (see e.g., fig. 1C and the associated pars.), wherein the connector comprises;
a valve body (260) that has a disk shape and that opens during delivery of the liquid medicine to allow the liquid medicine supply device to communicate with the tube (“FIG. 3, contrast media inlet port 240 is tapered outward (in the forward flow direction, i.e., from right to left in FIG. 3) to create a pocket 245 in front of an elastomeric disc 260 so that as fluid travels through the contrast media inlet port 240 and into the empty pocket, air is forced from the pocket (purged) through the disc slit 270 and into the valve body 220 (more precisely, into the cavity in the valve body which is adapted to fluid flow). Thus, for example, in an angiographic procedure, as contrast media fills the empty pocket 245 of the disc holder 255 and pressure builds, the elastomeric valve disc 260 bends and eventually opens the slit 270” [0058]), and
a valve seat that is provided on a tube side with respect to the valve body, the valve seat protruding toward the valve body so that the valve body contacts the valve seat (see fig. 3 and the associated pars.) wherein;
the valve body has an opening/closing hole that has a slit shape and that passes through the valve body in an axial direction at a central part (270); and
the valve seat has an inclined portion inclined radially inward toward the tube (see e.g., (280) as seen in fig. 3 and the associated pars).
Although, it is a common knowledge that is within the skilled artisan and it is also an obvious design choice to have a valve seat that is annular, in an effort to provide compact prosecution, Py has been introduced to show the teaching of valve seat that is annular as shown in detail below.
In the same field of endeavor, Py teaches to create a hermetically-sealed compartment for storage of the preparation in the syringe, compartment(s) for storage of the preparation is filled by inserting a needle through the fusible stopper into the storage compartment. As the storage compartment is filled, the air in the storage compartment is allowed to escape through an annular one-way valve formed on the outer periphery of the fusible stopper [0016]. The peripheral wall 28, an annular raised portion or protuberance 34 dimensioned to be frictionally received within the chamber 18 of the syringe body 12 further seals the plunger assembly 14 and prevents air from contacting the medicament contained within the syringe. At the top of the peripheral wall 28, a one-way valve is formed by a wedge-shaped, flexible annular flap 36, which is shaped and dimensioned to be flexible and to contact the inside of the syringe body 12 to form the annular one-way valve [0038] also see fig. 2 and the associated pars.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with valve seat that is annular as taught by Py because to provide a syringe that can be filled with a sterile substance, such as a vaccine, medicament or other pharmaceutical preparation, while maintaining the sterility of the syringe and substance during filling and storage thereafter ([0006] of Py).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Griggs (WO2012151542A2 the US equivalent of US20130123619A1 cited below) in view of Py (US 20100276035 A1) and Rajendran et al (US 20140073926 A1, hereinafter “Raj”).
Regarding claim 6, Griggs teaches a liquid medicine administration device comprising;
a needle unit (“medical fluid injection systems” [0002]; “a plunger within the syringe assembly 80A” [0040]) comprising;
catheter (a patient line (e.g., catheter) 102 [0044])
an inner needle passing through an inside of the catheter (“injector that includes a first syringe chamber in fluid communication with a tubing system” [0011]),
a hub that holds a proximal end of the catheter (see e.g., figs 1, 2, and 7 as well as the associated pars), and
a liquid medicine supply device comprising a container configured to store a liquid medicine (e.g., , a first fluid reservoir and a second fluid reservoir [0010]; “reservoir 40 comprises a bag” [0035]);
a tube configured to receive the liquid medicine from the liquid medicine supply device, the tube having a distal end connected to the hub (see e.g., fig. 1C and the associated pars.); and
a connector (104) to which the liquid medicine supply device is attached, the connector being located at a proximal end of the tube (see e.g., fig. 1C and the associated pars.), wherein the connector comprises;
a valve body (260) that has a disk shape and that opens during delivery of the liquid medicine to allow the liquid medicine supply device to communicate with the tube (“FIG. 3, contrast media inlet port 240 is tapered outward (in the forward flow direction, i.e., from right to left in FIG. 3) to create a pocket 245 in front of an elastomeric disc 260 so that as fluid travels through the contrast media inlet port 240 and into the empty pocket, air is forced from the pocket (purged) through the disc slit 270 and into the valve body 220 (more precisely, into the cavity in the valve body which is adapted to fluid flow). Thus, for example, in an angiographic procedure, as contrast media fills the empty pocket 245 of the disc holder 255 and pressure builds, the elastomeric valve disc 260 bends and eventually opens the slit 270” [0058]), and
a valve seat that is provided on a tube side with respect to the valve body, the valve seat protruding toward the valve body so that the valve body contacts the valve seat (see fig. 3 and the associated pars.) wherein;
the valve body has an opening/closing hole that has a slit shape and that passes through the valve body in an axial direction at a central part (270); and
the valve seat has an inclined portion inclined radially inward toward the tube (see e.g., (280) as seen in fig. 3 and the associated pars).
Although, it is a common knowledge that is within the skilled artisan and it is also an obvious design choice to have a valve seat that is annular, in an effort to provide compact prosecution, Py has been introduced to show the teaching of valve seat that is annular as shown in detail below.
In the same field of endeavor, Py teaches to create a hermetically-sealed compartment for storage of the preparation in the syringe, compartment(s) for storage of the preparation is filled by inserting a needle through the fusible stopper into the storage compartment. As the storage compartment is filled, the air in the storage compartment is allowed to escape through an annular one-way valve formed on the outer periphery of the fusible stopper [0016]. The peripheral wall 28, an annular raised portion or protuberance 34 dimensioned to be frictionally received within the chamber 18 of the syringe body 12 further seals the plunger assembly 14 and prevents air from contacting the medicament contained within the syringe. At the top of the peripheral wall 28, a one-way valve is formed by a wedge-shaped, flexible annular flap 36, which is shaped and dimensioned to be flexible and to contact the inside of the syringe body 12 to form the annular one-way valve [0038] also see fig. 2 and the associated pars.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with valve seat that is annular as taught by Py because to provide a syringe that can be filled with a sterile substance, such as a vaccine, medicament or other pharmaceutical preparation, while maintaining the sterility of the syringe and substance during filling and storage thereafter ([0006] of Py).
The above noted combination does not teach the limitation of a sealing body configured to affix the hub to a body surface.
However, in the same field of endeavor, Raj teaches the catheter 302, and the proximal hub 306 of the catheter 302 is secured to the patient's skin with adhesive tape applied to the hub and wings 308, 310 [0237].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with affix the hub to a body surface as taught by Raj because this would be an improved continuous anesthesia nerve conduction apparatus ([0015] of Raj).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797