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 limitation “an associated drive unit”, “a patient tube”, “a cassette holder with a receiving chamber … opened and closed” in claim 14; the limitation “heating device” in claims 22 & 30; the limitation “certain regions” in claim 22the limitation “a radiation-absorbing coating that is provided in some regions of the control cassette” in claim 23; the limitation “some regions” in claim 23; the limitation “an interchangeable unit” in claim 24; the limitation “the control cassette is embodied with an identification” in claim 26 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 14-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 14-16 state that a medical high-pressure injector, a patient tube, a syringe holder with an associated drive unit for the syringe held therein as well as connecting lines…., the injector having a cassette holder with a receiving chamber that can be opened and closed into which the control cassette can be interchangeably inserted, without providing any supporting interconnecting mechanical elements above to get the result. The disclosure does not provide enough information to show in the drawings that how are these elements above being connected/located in the medical high-pressure injector system.
Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know how to get the claimed result, as required in the claimed limitations above.
The breadth of the claims is large simply because a result is claimed instead of any particular structural configuration. As indicated above, how are these limitation above being connected or located in the medical high-pressure injector without providing enough structure features in the drawings?
Thus, one having ordinary skill in the art would not be able to make or use the invention in its entire scope without guidance has been disclosed as to how to determine what design to use. Applicant may argue that one in the art would know how to make and use the invention; however, this would not be persuasive because the disclosure fails to include the connection in between these elements as said the above with the high-pressure injection without providing enough information or providing clearly claimed features that should be shown in the drawings.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what structure of the elements above that being provided in the high-pressure injector, one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine the claimed features or the structure of these claimed features that listed above and therefore the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention, one would have to experiment unduly to reach the claimed result and thus the invention is not enabled.
In claim 22-26 & 30, the limitation, i.e., the control cassette is equipped with a heating device for the liquid that is conveyed through the connecting line, in claims 22 & 30, the limitation, i.e., the heating device is formed by a radiation-absorbing coating that is provided in some regions of the control cassette, in claim 23 without providing any supporting interconnecting mechanical elements above to get the result. The disclosure does not provide enough information to show in the drawings that how/where are these elements above being connected/located in the control cassette? The “some regions of the control cassette” is vague. The disclosure lacks providing location of the radiation-absorbing coating being provided in some regions of the control cassette.
Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know what to get the claimed result or how to make the claimed invention, as required above.
The breadth of the claims is large simply because a result is claimed instead of any particular structural configuration. Due to this broad scope, one having ordinary skill in the art would not be able to make or use the invention in its entire scope without undue experimentation because no explanation or guidance has been disclosed as to how to determine what design to use. Applicant may argue that one in the art would know how to make and use the invention; however, this would not be persuasive because the disclosure fails to include a heating device formed by a radiation-absorbing coating being provided in “some regions” without undue experimentation due to the broad nature of the claims.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what structure and location of the heating device formed by a radiation-absorbing coating, one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine the structure and location of the heating device formed by radiation-absorbing coating and therefore the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention, one would have to experiment unduly to reach the claimed result above and thus the invention is not enabled.
The claims 24-26 are also 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 14-33 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 “…for injection a liquid provided in a syringe into a patient” in in claim 14 is permeable. In other words, the claimed “syringe” is not a positive limitation. And then, the claim further requires that an associated drive unit for the syringe. Therefore, it is unclear to Examiner that the claimed “syringe” is a part of the medical high-pressure injector or just an intended use purpose. In case, Applicant would like to claim “a syringe” being a part of the high-pressure injection, then, the limitation “a syringe” should be changed to a positive limitation but not a permeable limitation, as indicated in the claim 14.
The other claims 15-33 are being rejected due to their dependency.
The limitation “wherein the injector has at least one syringe holder with an associated drive unit for the syringe held therein as well as connecting lines…” in claim 14 is vague. It is unclear to Examiner that which element, i.e., a syringe holder, an associated drive unit or a syringe holds connecting lines? Does Applicant mean that the syringe holds the associated drive unit and the connecting lines? The other claims 14-33 are being rejected due to their dependency.
The limitation “… a cassette holder with a receiving chamber that can be opened and closed” in claim 14 is vague. It is unclear to Examiner that which element, i.e., a cassette holder or a receiving chamber is able to open and close? In addition, the Fig. 5 shows that the receiving chamber is being located inside the cassette holder; however,
it is unclear to Examiner that where is a location of the cassette holder being located in the high-pressure injector?
In claim 14, the conjunction “and/or” is vague. It is unclear to Examiner that the following limitation, i.e. for filling the syringe that is held in the syringe holder needs to include or not include in the claim 14. The other claims 14-33 are being rejected due to their dependency.
In claim 14, the limitation “the injector having a cassette holder…” is vague. It is unclear to Examiner that how is the injector being provided a cassette holder? Where is the cassette holder located in the injector?
In claim 14, the limitation “… into which the control cassette can be interchangeably inserted” is vague. It is unclear to Examiner the interchangeably inserted of which element? Where is the control cassette can be “interchangeably inserted” to where or to which element? The other claims 15-33 are being rejected due to their dependency.
In claims 16-26, the limitation ‘wherein in the surface of the hard part that is on the opposite side from the routing surface” in claim 16 is vague. The Fig. 1 shows that the routing surface 300 is a part of hard part 30. Therefore, it does not make sense that the surface of the hard part is located on the opposite side of the routing surface. The other claims 17-26 are rejected due to their dependency.
In claim 16, the limitation “… the cassette holder is equipped with plungers, which are associated with the valve segment of the inserted control cassette…” is vague. Based on the Fig. 5, it is unclear to Examiner that how are the plunger being associated or connected with the valve segment? is the plunger being part of the valve? Where is the plunger being located in the Fig. 4?
Claim 16 recites the limitation "the opposite side" in in line 2. There is insufficient antecedent basis for this limitation in the claim.
In claims 18-19 & 28, the limitation: a device for separating gas bubbles from a liquid flowing through the connecting lines, is vague. The Fig. 2 shows that the connecting lines are formed as a device 33. Beside the connecting lines, the device 33 does not have other special feature for separating gas bubbles from a liquid. Therefore, it is unclear to Examiner that is the device 33 including other element beside the connecting lines for separating gas bubbles from a liquid?
In claim 19, the limitation “… whose radius extends in a vertically oriented plane…” is vague. It is unclear to Examiner that the radius is belonging to which element, i.e., the device, a circular arc shape, line segments, or connecting lines?
In claims 22 & 30, the limitation “wherein certain regions...” is vague. It is unclear to Examiner that which regions are they? Where are they located?
In claim 23, the limitation “… in some regions of the control cassette…” is vague. It is unclear to Examiner that where are “some regions” being located? Which elements are referring to “some regions”? In addition, the limitation “… a radiation-absorbing coating that is provided in some regions of the control cassette and an associated light source …” in claim 23 is vague. It is unclear to Examiner that the radiation-absorbing coating is only provided in some regions of the control cassette, or the radiation-absorbing coating is provided in some regions of the control cassette and the associated light source?
In claims 24 & 31, the limitation “an interchangeable unit” is vague. It is unclear to Examiner that which element is designated to “an interchangeable unit”?
In claims 26, 30 & 33, the limitation “an identification” is vague. It is unclear to Examiner that which element is designated to “an identification”? Where is the location of the identification being located in the control cassette?
Claims 14-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted element is a medical high-pressure injector.
The other claims 15-33 are being rejected due to their dependency.
Claims 14-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: a medical high-pressure injector being connected with a syringe, a control cassette and cassette holder. The claimed invention requires a medical high-pressure injector. However, nowhere in the drawings show a whole unit of the medical high-pressure injector. Examiner acknowledges that a syringe, an associated drive unit, a control cassette, cassette holder and other units are being parts of the high-pressure injector. However, it is unclear to Examiner that how is/are the associated drive unit, a control cassette, a cassette holder being located or connected with the high-pressure injector.
The other claims 15-33 are being rejected due to their dependency.
In claims 22-23 & 30, the omitted structural cooperative relationships are: the control cassette is equipped with a heating device; wherein the heating device is formed by a radiation-absorbing coating that is provided in some regions of the control cassette and an associated light source in the receiving chamber. It is unclear to Examiner that where are these elements, i.e. heating device, a radiation-absorbing coating, an associated light source being located in the control cassette?
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Uber, III et al. (US 11,013,857) in view of Haddad et al. (US 9,604,014).
Regarding claim 14, Uber discloses a medical high-pressure injector 10 in Fig. 2 for injecting a liquid provided in a syringe (similar to a syringe 12a/12b in Fig. 1) into a patient, wherein the injector 10 has at least one syringe holder (a housing to hold the syringe) with an associated drive unit (e.g., plunger or driving unit located inside a power actuator injector 67) for the syringe held therein as well as connecting lines (tubing lines, similar element 17 in Fig. 1) for transmitting the liquid from the syringe into a patient tube 69 and/or for filling the syringe that is held in the syringe holder,
the high-pressure injector comprising the connecting lines embodied in an interchangeable control cassette 20 (Fig. 2) or element 56 (Fig. 3) and the injector having a cassette holder (a rectangular housing that where is holding the heating system 20) with a receiving chamber 56 into which the control cassette 20 can be interchangeably inserted (or replaced).
Uber does not disclose that the cassette holder that can be opened and closed.
Haddad discloses an injector comprising: an interchangeable control cassette 300 in Figs. 38-56 with a receiving chamber 315/330/335 (wherein a tubing DL is inserted into the chambers 315/330/335); wherein the cassette holder can be opened and closed (via a door 425, Fig. 42) into which the control cassette 300 can be interchangeably/replaceable inserted.
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 interchangeable control cassette device of Uber, with including tubing, a receiving chamber, a cassette holder that being opened and closed, as taught by Haddad, in order to prevent the entrapment of air in a fluid introduced into a patient.
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Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857).
Regarding claim 14, Haddad discloses an instrument, injector, col. 1, lines 54-55 for injection through tubing, catheter into a patient. Note: a person skilled in the art would recognize that an interchangeable/replaceable control cassette 300 (in Figs. 38-56) can be connected to the injector for drug delivery, as modified by Uber below.
the injector comprising: connecting lines (Note: the tubing being located in chambers 315, 330, 350, similar to tubing lines 15, in Fig. 18) embodied in an interchangeable/replaceable control cassette 300 (in Figs. 38-56); the injector having a cassette holder 400 & 425 with a receiving chamber 315, 330 & 350; wherein the cassette holder can be opened and closed, into which the control cassette can be interchangeably/replaceable inserted.
Haddad does not disclose that the injector is as a high-pressure injector; a syringe holder with associated drive unit for the syringe held therein as well as connecting lines for transmitting the liquid from the syringe into a patient tube and/or filling the syringe that is held in the syringe holder.
Uber discloses a medical high-pressure injector 10 in Fig. 2 for injecting a liquid provided in a syringe (similar to a syringe 12a/12b in Fig. 1) into a patient, wherein the injector 10 has at least one syringe holder (a housing to hold the syringe) with an associated drive unit (e.g., plunger or driving unit located inside a power actuator injector 67) for the syringe held therein as well as connecting lines (tubing lines, similar element 17 in Fig. 1) for transmitting the liquid from the syringe into a patient tube 69 and/or for filling the syringe that is held in the syringe holder.
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 injector device of Haddad, with providing a high-pressure injector that having a syringe holder, an associated drive unit for the syringe, as taught by Uber, for providing benefits of faster delivery of fluid in precise flow rate and volumes.
Note: A medical high-pressure injector of Haddad in view of Uber includes that: the outlet port 320 connects to the injector 67 (as modified by Uber) for filling the syringe of the injector 67 via tubing 17 (similar Fig. 1 of Uber), and then the fluid from the injector 67 passes through the tubings 17 & 69 into a patient.
Claims 15-20, 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857) and further in view of Fulkerson et al. (US 2017/0021085)
Regarding claim 15, Haddad in view of Uber discloses all the claimed subject matter as required. Haddad further discloses that wherein the control cassette 300 comprises an at least a two-part construction with a hard part 305; wherein line segments 315, 330, 350 of the connecting lines are provided in a surface of the hard part embodied as a routing surface (a surface of the body 305, Fig. 38.
Haddad in view of Uber fails to disclose at least one diaphragm; wherein the diaphragm is mounted on the routing surface in a liquid- tight way and covers the line segments in the hard part.
Fulkerson discloses a disposal manifold/cassette 200 in Fig. 2comprising: a hard part 204 and at least one diaphragm 201 & 205; wherein a diaphragm is mounted on a routing surface (a front & back surface of the hard part 204) in a liquid tight way and covers the lines segments in the hard part.
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 control cassette device of Haddad (or Haddad in view of Uber with providing at least one diaphragm that being mounted on the routing surface of the control cassette, as taught by Fulkerson, in order to prevent leaking and corrosive.
Regarding claim 16, Haddad in view of Uber discloses all the claimed subject matter as required. As best as understood, Haddad further discloses that wherein in the surface of the hard part that is on the opposite side from the routing surface and is embodied as a valve surface 345/360/365 and is covered by a diaphragm (as modified by Fulkerson, in the claim 15), which is mounted on the valve surface in a liquid-tight way, valve segments 345/360/365 of the connecting lines communicate with the line segments via connecting bores, which pass through the hard part from the routing surface to the valve surface, and jointly form the connecting lines, and the cassette holder 400/425 is equipped with plungers (see the marked-up Fig. 42 below), which are associated with the valve segments of the inserted control cassette (3) and can be slid forward into the receiving chamber in order to exert a force of pressure on the diaphragm in the region of the associated valve segment and to at least partially close the valve segment.
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Regarding claims 17 & 27, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Fulkerson discloses that the hard part made of plastic; the diaphragm is made of a plastic film (polycarbonate material or ABS, para [0068]. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain these materials as required in the claim 27, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
It is noted that the product-by-process limitation “injection-molded” and “welded” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claims 18 & 28, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that the connecting lines embodied in the control cassette comprise a device (as best as understood, a whole unit of the fluid line inside the body 300 and/or purge port 325) for separating gas bubbles from a liquid flowing through the connecting lines, col. 13, lines 25-35.
Regarding claim 19, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that wherein the device (as best as understood, a whole unit of the fluid line inside the body 300 and/or purge port 325) for separating the gas bubbles comprises a conduit (tubing), extending in a circular arc shape and communicating with line segments of the connecting lines and whose radius extends in a vertically oriented plane, and wherein a gas outlet opening is provided at the highest point of the device and the conduit tapers in the flow direction of the liquid.
Regarding claims 20 & 29, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that the control cassette comprises an optical detection device 335 or 415 in a line segment, Fig. 38 & 42.
Regarding claim 30, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that wherein in certain regions, the control cassette 300 is equipped with a heating device 500 for the liquid that is conveyed through the connecting lines. In addition, Uber also discloses a heating device 28 for the liquid that is conveyed through the connecting lines.
Regarding claim 31, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that wherein the control cassette 300 and at least one syringe (as modified by Uber) are combined into an interchangeable unit (as best as understood, an interchangeable unit 400 & 425 or the high-pressure injector) and connected to each other and can be jointly inserted into the receiving chamber 315, 330 & 350, and the syringe holder.
Regarding claim 32, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses that , wherein the receiving chamber 315, 330 & 350 and/or the control cassette 300 is each equipped with a correctly positioned insertion of the control cassette 300 into the receiving chamber 315, 330 & 350.
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857) & Fulkerson et al. (US 2017/0021085) and further in view of Augustin et al. (US 5,704,130).
Regarding claim 21, Haddad in view of Uber & Fulkerson discloses all the claimed subject matter as required. Haddad discloses a sensor 415, two prisms (2 vertical boxes 415/420 in Fig. 42) positioned on opposite sides relative to a line segment
Haddad in view of Uber & Fulkerson does not disclose that one deflecting prism is associated with a light source positioned in the wall of the receiving chamber and by this deflecting prism, the light beam can be guided through the line segment to the opposing deflecting prism and the deflecting prism is associated with a sensor 415 positioned in the wall of the receiving chamber.
Augustin discloses that an optical measuring device (a detection device) in Figs. 5-6 to indicate bubbles comprising: a light source 13, a sensor 21; wherein the detection device comprising: two deflecting prisms 4 on opposite sides relative a line; wherein one deflecting prism 4 is associated with a light source 13 and by this deflecting prism, the light beam 15 can be guided through the line segment 3 to the opposing deflecting prism and the deflecting prism is associated with a sensor 21.
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 optical detection device of Haddad (or Haddad in view of Uber & Fulkerson) with providing one deflecting prism being associated with a light source positioned in the wall of the receiving chamber and by this deflecting prism, the light beam can be guided through the line segment to the opposing deflecting prism and the deflecting prism is associated with a sensor positioned in the wall of the receiving chamber, as taught by Augustin, in order to improve a measuring accuracy of the gas bubble in the tubing line.
Regarding claim 22, Haddad in view of Uber & Fulkerson and further in view of Augustin discloses all the claimed subject matter as required. Haddad discloses that wherein in certain regions, the control cassette 300 is equipped with a heating device 500 for the liquid that is conveyed through the connecting lines. In addition, Uber also discloses a heating device 28 for the liquid that is conveyed through the connecting lines.
Regarding claim 23, Haddad in view of Uber & Fulkerson and further in view of Augustin discloses all the claimed subject matter as required. It is well-known in the art that a radiation-absorbing coating and a light source are provided in the radiation heating device for heating the object directly in high energy efficiency.
Regarding claims 24-26, these claims are being rejected using same analysis with these claims 31-33.
Claims 15-20, 27-32 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857) and further in view of Mitsunaga et al. (US 2002/0081109).
Regarding claim 15, Haddad in view of Uber discloses all the claimed subject matter as required. Haddad further discloses that wherein the control cassette 300 comprises an at least a two-part construction with a hard part 305; wherein line segments 315, 330, 350 of the connecting lines are provided in a surface of the hard part embodied as a routing surface (a surface of the body 305, Fig. 38.
Haddad in view of Uber fails to disclose at least one diaphragm; wherein the diaphragm (31.1) is mounted on the routing surface in a liquid- tight way and covers the line segments in the hard part.
Mitsunaga discloses a disposal cartridge/cassette comprising: a hard part 206 and at least one diaphragm 202 & 204; wherein a diaphragm is mounted on a routing surface 206 in a liquid tight way and covers the lines segments 210 in the hard part.
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 control cassette device of Haddad (or Haddad in view of Uber with providing at least one diaphragm that being mounted on the routing surface of the control cassette, as taught by Mitsunaga, in order to prevent leaking and corrosive.
Regarding claim 16, Haddad in view of Uber discloses all the claimed subject matter as required. As best as understood, Haddad further discloses that wherein in the surface of the hard part that is on the opposite side from the routing surface and is embodied as a valve surface 345/360/365 and is covered by a diaphragm (as modified by Mitsunage, in the claim 15), which is mounted on the valve surface in a liquid-tight way, valve segments 345/360/365 of the connecting lines communicate with the line segments via connecting bores, which pass through the hard part from the routing surface to the valve surface, and jointly form the connecting lines, and the cassette holder 400/425 is equipped with plungers (see the marked-up Fig. 42 below), which are associated with the valve segments of the inserted control cassette (3) and can be slid forward into the receiving chamber in order to exert a force of pressure on the diaphragm in the region of the associated valve segment and to at least partially close the valve segment.
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Regarding claims 17 & 27, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Mitsunaga discloses that the hard part made of plastic; the diaphragm is made of a plastic film, para [0035-0037]. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain these materials as required in the claim 27, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
It is noted that the product-by-process limitation “injection-molded” and “welded” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Regarding claims 18 & 28, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that the connecting lines embodied in the control cassette comprise a device (as best as understood, a whole unit of the fluid line inside the body 300 and/or purge port 325) for separating gas bubbles from a liquid flowing through the connecting lines, col. 13, lines 25-35.
Regarding claim 19, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that wherein the device (as best as understood, a whole unit of the fluid line inside the body 300 and/or purge port 325) for separating the gas bubbles comprises a conduit (tubing), extending in a circular arc shape and communicating with line segments of the connecting lines and whose radius extends in a vertically oriented plane, and wherein a gas outlet opening is provided at the highest point of the device and the conduit tapers in the flow direction of the liquid.
Regarding claims 20 & 29, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that the control cassette comprises an optical detection device 335 or 415 in a line segment, Fig. 38 & 42.
Regarding claim 30, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that wherein in certain regions, the control cassette 300 is equipped with a heating device 500 for the liquid that is conveyed through the connecting lines. In addition, Uber also discloses a heating device 28 for the liquid that is conveyed through the connecting lines.
Regarding claim 31, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that wherein the control cassette 300 and at least one syringe (as modified by Uber) are combined into an interchangeable unit (as best as understood, an interchangeable unit 400 & 425 or the high-pressure injector) and connected to each other and can be jointly inserted into the receiving chamber 315, 330 & 350, and the syringe holder.
Regarding claim 32, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses that , wherein the receiving chamber 315, 330 & 350 and/or the control cassette 300 is each equipped with a correctly positioned insertion of the control cassette 300 into the receiving chamber 315, 330 & 350.
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857) & Mitsunaga et al. (US 2002/0081109) and further in view of Augustin et al. (US 5,704,130).
Regarding claim 21, Haddad in view of Uber & Mitsunaga discloses all the claimed subject matter as required. Haddad discloses a sensor 415, two prisms (2 vertical boxes 415/420 in Fig. 42) positioned on opposite sides relative to a line segment
Haddad in view of Uber & Mitsunaga does not disclose that one deflecting prism is associated with a light source positioned in the wall of the receiving chamber and by this deflecting prism, the light beam can be guided through the line segment to the opposing deflecting prism and the deflecting prism is associated with a sensor 415 positioned in the wall of the receiving chamber.
Augustin discloses that an optical measuring device (a detection device) in Figs. 5-6 to indicate bubbles comprising: a light source 13, a sensor 21; wherein the detection device comprising: two deflecting prisms 4 on opposite sides relative a line; wherein one deflecting prism 4 is associated with a light source 13 and by this deflecting prism, the light beam 15 can be guided through the line segment 3 to the opposing deflecting prism and the deflecting prism is associated with a sensor 21.
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 optical detection device of Haddad (or Haddad in view of Uber & Mitsunaga) with providing one deflecting prism being associated with a light source positioned in the wall of the receiving chamber and by this deflecting prism, the light beam can be guided through the line segment to the opposing deflecting prism and the deflecting prism is associated with a sensor positioned in the wall of the receiving chamber, as taught by Augustin, in order to improve a measuring accuracy of the gas bubble in the tubing line.
Regarding claim 22, Haddad in view of Uber & Mitsunaga and further in view of Augustin discloses all the claimed subject matter as required. Haddad discloses that wherein in certain regions, the control cassette 300 is equipped with a heating device 500 for the liquid that is conveyed through the connecting lines. In addition, Uber also discloses a heating device 28 for the liquid that is conveyed through the connecting lines.
Regarding claim 23, Haddad in view of Uber & Mitsunaga and further in view of Augustin discloses all the claimed subject matter as required. It is well-known in the art that a radiation-absorbing coating and a light source are provided in the radiation heating device for heating the object directly in high energy efficiency.
Regarding claims 24-26, these claims are being rejected using same analysis with these claims 31-33.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al. (US 9,604,014).in view of Uber, III et al. (US 11,013,857) and further in view of Mounce et al. (US 10,092,703).
Regarding claim 33, Haddad in view of Uber discloses all the claimed subject matter as required except for the limitation that: the control cassette 300 is embodied with an identification which is readable from the high-pressure injector when a control cassette (3) is inserted into the receiving chamber (110).
Mounce discloses an autoinjector device comprising: a control cassette 600 is embodied with an identification 410/410t which is readable from the injector when a control cassette 600 is inserted into the receiving chamber 301 for verifying that the cassette 600 is an authorized OEM device, and/or verifying the proper insertion of the cassette 600 into the autoinjector, col. 19, lines 30-50, in Figs. 9-12B.
Giving such a teaching by Mounce, a person having ordinary skill in the art would have easily recognizes that modifying the device of Haddad in view of Uber with including an identification located on/in control cassette, as taught by Mounce, would provide the benefits of verifying that the cassette being an authorized OEM device, and/or verifying the proper insertion of the cassette into the autoinjector, col. 19, lines 30-50, in Figs. 9-12B.
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
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783