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 02/04/26 has been entered in the case. Claims 2-8, 21-25 are pending for examination and claims 1, 9-20 are cancelled.
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 2-8, 21-25 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.
Nowhere in the elected Figs. 4 & 7A have described the combination of the limitations (hereinafter) in the same infusion pump system, i.e. “wherein the feature element of the first port of the infusion pump is complementary in shape to the feature element of the inlet port of the first tube and the feature element of the second port of the infusion pump is complementary in shape to the feature element of the inlet port of the second tube, ... wherein the feature elements of the first and second ports of the infusion pump are positioned, respectively, on first and second caps configured to engage with the first and second ports of the infusion pump”.
Based on the elected Fig. 4 below, it shows that the first and second caps 68 & 78 are engaged to the first and second ports 64 & 72 (respectively); however, the Fig. 4 does not show that the feature element of the first port 64 is complementary in shape to the feature element of the inlet port of the first tube; and the feature of the second port 72 is complementary in shape to the feature element of the inlet port of the second tube.
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Based on the elected Fig. 7A below, it shows that the feature element 114 (Female connector) of the first port 102 of the infusion pump is complementary in shape to the feature element 116 (Male connector) of the inlet port of the first tube 116 and the feature element 116 (Male connector) of the second port 104 of the infusion pump is complementary in shape to the feature element (Female connector) of the inlet port of the second tube 114. However, the Fig. 7A does not include first and second caps. Assuming that the elements 102 & 104 are equivalent to the first and second caps, in that case, which elements are being designated to the first and second port of the pump?
In other words, the pump device 12 in Fig. 7A does not include the claimed feature, i.e., wherein the feature elements of the first and second ports of the infusion pump are positioned, respectively, on first and second caps configured to engage with the first and second ports of the infusion pump, as required in the claim 2.
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The other claims 3-8, 21-25 are being rejected due to their dependency.
In claims 21-22, the claim 22 requires that “the first and second caps permanently mate to the first and second reservoirs”, this limitation is contradicted with the limitation “the first and second reservoirs removably positioned within first and second manifolds” in claim 21. In Fig. 4, if the caps 68 & 78 permanently mate/lock the reservoirs 16A/16B. In other words, the reservoirs 16A/16B are being permanently locked by the caps 68 & 78. In that case, how is possible that the reservoirs 16A/16B being removed within the first and second manifold.
The other claims 23-25 are being rejected due to their dependency.
In claim 22, nowhere in the elected Figs. 4 & 7 have described that the second cap permanently mates to the second reservoir. Examiner acknowledges that the first cap 68 permanently mates with a feature of the inlet of the pump, para [0102]. However, the second cap 78 is a standard cap that secures on the reservoir 16B, but nowhere in the original specification mentions that the second cap 78 is permanently mated to the second reservoir 16B.
The other claims 23-25 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 21-25 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 21, the limitation “... the first reservoir and manifold and the second reservoir and manifold...” in claim 21 is vague. It is unclear to Examiner that the limitation “manifold” is being referred to first or second manifold?
The Fig. 4 shows that the manifolds 14A & 14B are vague. Assuming the manifolds 14A & 14B are positioned at #64 & #72, in that case, the first and second reservoirs 16A & 16B are not positioned within the first and second manifolds. The first and second reservoir 16A & 16B are located outside of the manifolds 14A & 14B. Another assuming that if the manifolds 14A & 14B are equivalent to chamber that wherein the reservoir 16A & 16B are inserted therein. In that case, the feature elements of the chambers 16A & 16B are same shape (rectangular shape). In other words, the first reservoir can be inserted into the first manifold/chamber and vice versa.
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 2, 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over LaFond (US 4,563,175) in view of Mason et al. (US 2002/0019608).
Regarding claim 2, LaFond discloses a system for delivering multiple fluids to a patient, in Fig. 1, comprising:
an infusion pump 1 having first and second ports 76 & 77 associated therewith, wherein the first and second ports have a feature element (different size) associated therewith,
Note: a syringe 3 is large syringe; a syringe 4 is small syringe. Therefore, the ports 76 & 77 are different size. For example: the port 76 has larger diameter and larger length compare with the port 77.
the system characterized in further having:
a multi-channel lumen assembly (Y-shaped tubing 98 & 109) having: a first tube 98 having an inlet port 100 fluidly coupled to the first port 76 of the infusion pump and an outlet port 106, and a second tube 109 having an inlet port 111 fluidly coupled to the second port 77 of the infusion pump and an outlet port 108
wherein the inlet port 100 of the first tube 98 of the multi-channel lumen assembly has a feature element 99 & 100 (or a T-connector) associated therewith and the inlet port 111 of the second tube 109 of the multichannel lumen assembly has a feature element 111 & 112 (or T-shaped in different configuration with respect to the feather element 99 & 100 or T-connector at the first tube 98) associated therewith,
wherein the feature element, i.e., larger size of the first port 76 of the infusion pump is complementary in shape to the feature element (99 & 100 or a T-connector in large size and different configuration compare with the T-connector at 113) of the inlet port 100 of the first tube 98 and the feature element, i.e., smaller size of the second port 77 of the infusion pump is complementary in shape to the feature element (T-shaped connector in different size & different configuration compare with the T-connector 102) of the inlet port of the second tube, such that when assembled the first port is capable of only being fluidly coupled to the inlet port of the first tube and the second port is capable of only being fluidly coupled to the inlet port of the second tube, thereby preventing mischanneling of the fluid.
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LaFond does not disclose that the feature elements of the first and second ports of the infusion pump are positioned, respectively, on first and second caps configured to engage with the first and second ports of the infusion pump.
Mason discloses a system for delivering multiple fluids to a patient, comprising: a infusion pump10 comprising: a first port 86, second port 88; a fist cap 34; a second cap 36; wherein the feature of the first and second cap are different for preventing mischanneling the fluid and enhancing coupling in between the inlet ports of the tubes and the outlet ports of the infusion pump.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the system in LaFond with providing a first and second caps being engaged with the first and second port of the pump, as taught by Mason, in order to preventing mischanneling of the fluid and enhancing coupling in between the inlet ports of the tubes and the outlet ports of the infusion pump.
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Regarding claim 21, as best as undesrtood, wherein the first and second ports of the infusion pump are respectively assoacitaed with first and second reservoirs removably positioned withih first and second manifolds (large and small chambers wherein the large and small reservoirs 6 &4 located therein); wherein the first reservoir 6 and a first manifold/chamber and the second reservoir 4 and second manifold/chamber each ompirses one or more features (e.g, the first manifold/chamber is larger than the second manifold/chamber) providing dissimilar engagement interfaces to such that the first reservoir (large reservoir) cannot engage with the second/small manifold.
Regarding claim 22, LaFond in view of Mason discloses all the claimed subject matter as required except of the limitation the that the first and second caps permanently mate to the first and second reservoirs. 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 caps permanently mate to the first and second reservoirs, since it has been held that constructing a formerly integral/permanently structure in various elements involves only routine skill in the art.
Regarding claim 23, LaFond in view of Mason discloses all the claimed subject matter as required; wherein the first and second caps (as modified by Mason)mate to surfaces on the infusion pump to capture the first and second reservoirs within he first and second manifolds.
Regarding claims 24-25, LaFond in view of Mason discloses all the claimed subject matter as required wherein the first and second caps (as modified by Mason) further comprises the one or more feature elements (i.e. different configurations, for example: one cap includes threads engagement, and the other provides a friction fit engagement, both of the caps have different shapes) providing dissimilar engagement interfaces for the first and second reservoir and manifolds; wherein the first reservoir comprises a feature that corresponds to a feature on the first cap so that the cap may mate with the first reservoir but not the second reservoir.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over LaFond (US 4,563,175) in view of Mason et al. (US 2002/0019608) and further in view of Aeschlimann et al. (US 8,992,507).
Regarding claim 3, LaFond in view of Mason discloses all the claimed subject matter as required except for the limitation that the feature element of the first port and the feature element of the inlet port of the first tube are formed a bayonet type fluid connection.
Aeschlimann discloses a system for delivering fluid to a patient comprising: a feature element 6b associated with a first port 6 of an infusion pump 4 (syringe) and a feature element 1a associated with the inlet port 2 of the first tube form a bayonet type fluid connection, col. 4, lines 45-col. 5, line 5 & Figs. 1-2; wherein a cap 1 configured to engage with ana port 7 of infusion pump 10.
Giving such a teaching by Aeschlimann, a person having ordinary skill in the art would have easily recognizes that modifying the connector in the port of the infusion pump and the inlet port of the tube in the device system of LaFond in view of Mason with providing feature element in the port of infusion pump and feature element in the inlet tube to form a bayonet type fluid connection, a cap being connected to a port of the pump, as taught by Aeschlimann, would provide the benefits of enhancing and firmly connection and quickly disconnecting in between the port of the infusion pump and the inlet port of the tube.
Claims 2, 4, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 2007/0088271) in view of Watt (US 4,150,673).
Regarding claim 2, Richards discloses a system for delivering multiple fluids to a patient, in Fig. 1, comprising:
an infusion pump 20 having first and second ports 22 & 24 associated therewith, wherein the first and second ports have a feature element associated therewith, the system characterized in further having:
a multi-channel lumen assembly 50/52 having: a first tube 50 having an inlet port (at proximal end of the first tube 50) fluidly coupled to the first port 22 of the infusion pump and an outlet port (distal end of the tube 50 being connected to an infusion head 54), and a second tube 52 having an inlet port (at proximal end of the first tube 52) fluidly coupled to the second port of the infusion pump and an outlet port (distal end of the tube 52 being connected to an infusion head 54),
wherein the inlet port of the first tube of the multi-channel lumen assembly has a feature element associated therewith and the inlet port of the second tube of the multichannel lumen assembly has a feature element associated therewith,
wherein the feature element of the first port of the infusion pump is complementary in shape to the feature element of the inlet port of the first tube and the feature element of the second port of the infusion pump is complementary in shape to the feature element of the inlet port of the second tube, such that when assembled the first port is capable of only being fluidly coupled to the inlet port of the first tube and the second port is capable of only being fluidly coupled to the inlet port of the second tube;
wherein the feature elements of the first and second ports 22 & 24 of the infusion pump are positioned, respectively, on the first and second caps (half-circle caps being engaged to the proximal end of the tubes 50 & 52) configured to engage with the first and second ports 22 & 24 of the infusion pump.
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Richards does not disclose that wherein the feature element associated with the first port of the infusion pump is different than the feature element associated with the second port of the infusion pump, and
wherein the feature element associated with the inlet port of the first tube of the multi-channel lumen assembly is different than the feature element associated with the inlet port of the second tube of the multi-channel lumen assembly.
Watt discloses a connector system comprising: a first port 9a, a second port 9b; wherein a feature element, i.e., circular shape 9a associated with the first port 9a is different than a feature element, i.e., rectangular shape 9b associated with the second port 9b; wherein a feature element, i.e., 11a & 12a associated with the inlet port 10a of a first tube 10a is different than the feature element, i.e., 11b & 12b associated with the inlet port 10b of a second tube 10b.
Giving such a teaching by Watt, it would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the first and second ports and first and second inlet ports of Richards with providing different feature elements in the first and second ports and providing different features of the first and second inlet port of the first and second tubes, as taught by Watt, in order to preventing mischanneling of the fluid.
Regarding claim 4, Richards in view Watt discloses all the claimed subject matter as required. Watt (or Richards in view of Watt) discloses that the feature elements (in ring-shaped 9a & disc-shaped 11a) of the first port 10a of the first tube 10a and the inlet port 10a of the first tube;
and the feature elements (rectangular-shaped 9b & 11b) of the second port 9b and the inlet port 10b of the second tube 10b comprise a male connector portion12a/12b and a female connector portion 8a & 9a -8b & 9b.
Regarding claim 21, Richards in view Watt discloses all the claimed subject matter as required. Richard discloses in Fig. 5 (different embodiment in Fig. 1, can be modified in the device system in Fig. 1) that a first and second ports of the infusion pump are respectively associated with the first and second reservoirs 126 & 128 removably positioned within first and second manifolds (i.e., a first manifold such as a standard manifold, i.e., the reservoir 38/126 being inserted into an interior space of the pump; and a second manifold includes a cubic box covering the second reservoir 128 and inserted into the inter space of the pump); wherein the first reservoir 126 and manifold and the second reservoir 128 and manifold each comprise one or more feature elements (different configurations in Fig. 5) cannot engage with the second manifold.
Giving such a teaching by Richards in Fig. 5, a person having ordinary skill in the art would have easily recognizes that modifying the in the device system of Richards in view of Watt with providing the first manifolds and first the reservoirs have different feature elements with respect to the second manifold and second reservoir, as taught by Richards in Fig. 5, for providing dissimilar engagement interface to such that the first reservoir cannot engage with the second manifold.
Regarding claim 22, Richards in view Watt discloses all the claimed subject matter as required except of the limitation the that the first and second caps permanently mate to the first and second reservoirs. 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 caps permanently mate to the first and second reservoirs, since it has been held that constructing a formerly integral/permanently structure in various elements involves only routine skill in the art.
Regarding claim 23, as best as understood, Richards discloses that the first and second caps (half-circle caps being engaged to the proximal end of the tubes 50 & 52) mate to surfaces on the infusion pump to capture the first and second reservoirs within he first and second manifolds (chambers in the infusion pump; wherein the first manifold has feature element of the first reservoir 128, as shown in Fig. 5).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 2007/0088271) in view of Watt (US 4,150,673) and further in view of Aeschlimann et al. (US 8,992,507).
Regarding claim 3, Richards in view Watt discloses all the claimed subject matter as required except for the limitation that the feature element of the first port and the feature element of the inlet port of the first tube are formed a bayonet type fluid connection.
Aeschlimann discloses a system for delivering fluid to a patient comprising: a feature element 6b associated with a first port 6 of an infusion pump 4 (syringe) and a feature element 1a associated with the inlet port 2 of the first tube form a bayonet type fluid connection, col. 4, lines 45-col. 5, line 5 & Figs. 1-2; wherein a cap 7 configured to engage with a first port 6 of the infusion pump
Giving such a teaching by Aeschlimann, a person having ordinary skill in the art would have easily recognizes that modifying the connector in the port of the infusion pump and the inlet port of the tube in the device system of Richards in view of Watt with providing feature element in the port of infusion pump and feature element in the inlet tube to form a bayonet type fluid connection, as taught by Aeschlimann, would provide the benefits of enhancing and firmly connection and quickly disconnecting in between the port of the infusion pump and the inlet port of the tube.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 2007/0088271) in view of Watt (US 4,150,673) and further in view of Cunningham (US 6,916,313).
Regarding claim 5, Richards in view of Watt discloses all the claimed subject matter as required. Richards further discloses in Fig. 5 that the first tube 122 and the second tube 124 of the multi-channel assembly includes an outer surface having a surface feature (smooth surface) associated therewith and the second tube 124 includes an outer surface having a surface feature (smooth surface) associated therewith; wherein the first and second tubes can be removably and replaceable together.
Richards in view of Watt fails to disclose that the surface features of the first and second tubes are complementary in shape and configured to engage with each other to coupled together the first and second tubes; and wherein the surface feature associated with the first tube is a rail type element and the surface feature associated with the second tube includes a channel that is sized and configured for receiving and seating the rail type element.
Cunningham discloses a multi-channel lumen assembly comprising: a first tube 14 and a second tube 12 are configured to be coupled together along at least a portion of a length of the assembly; wherein the first tube 14 includes an outer surface having a surface feature 40A-E (or 51) associated therewith and the second tube 12 includes an outer surface having a surface feature 40A-E (52) associated therewith, wherein the surface features of the first and second tubes are complementary in shape and configured to engage with each other to coupled together the first and second tubes, see Figs. 2-3A; and wherein the surface feature 40A-E (or 51) associated with the first tube 14 is a rail type element and the surface feature 40A-E (or 52) associated with the second tube 12 includes a channel that is sized and configured for receiving and seating the rail type element, wherein the first and second tubes can be removably and replaceable coupled together.
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 multi-channel lumen assembly of Richards in view of Watt with providing surface features located on the first and second tubes, as taught by Cunningham, in order to allow the first and second tubes can be removably and replaceably coupled together to prevent tangle during use.
Regarding claim 6, Richards in view of Watt and further in view of Cunningham discloses all the claimed subject matter as required. Richards further discloses in Figs. 2 & 5 that an infusion set having a first inlet port (being connected to the first port of the infusion pump) fluidly coupled to the outlet port (distal end of the first tube being connected to an infusion head 54/134) of the first tube 50/122, and a second inlet port (being connected to the first port of the infusion pump) fluidly coupled to the outlet port (distal end of the first tube being connected to an infusion head 54/134) of the second tube 52/124, wherein the infusion set is configured to deliver the fluids to the patient.
Regarding claim 7, Richards in view of Watt and further in view of Cunningham discloses all the claimed subject matter as required. Richard further discloses in the marked-up Fig. 2 below that: wherein the outlet port of the first tube 50 of the multi-channel lumen assembly has a feature element (standard outlet port, for example: smooth in & outer surface, see Fig. 2 in Richards) associated therewith, and the outlet port of the second tube 52 of the multi-channel lumen assembly has a feature element (standard outlet port for example: smooth in & outer surface, see Fig. 2 in Richards) associated therewith, and wherein the first inlet port of the infusion set 54 has a feature element (protrusion at inlet port) associated therewith and the second inlet port of the infusion set 54 has a feature element (protrusion at inlet port) associated therewith, wherein the feature element of the outlet port of the first tube of the multi- channel lumen assembly is complementary in shape to the feature element of the first inlet port, and the feature element of the outlet port of the second tube of the multi-channel lumen assembly is complementary in shape to the feature element of the second inlet port, such that when assembled the outlet port of the first tube is capable of only being fluidly coupled to the first inlet port and the outlet port of the second tube is capable of only being fluidly coupled to the second inlet port; optionally, wherein the infusion set has one or more piercing elements 62 associated therewith.
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Regarding claim 8, Richards in view of Watt and further in view of Cunningham discloses all the claimed subject matter as required. Richards further discloses in Fig. 5 that a first infusion set 130 fluidly coupled to the outlet port (distal end of the first tube 122) of the first tube 122, and a second infusion set 132 fluidly coupled to the outlet port (distal end of the second tube 124) of the second tube, wherein the infusion sets are configured to deliver the fluids to the patient. A person skilled in the art would recognize that the first and second infusion set in Fig. 5 can be provided in Fig. 1 in Richards.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 2007/0088271) in view of Watt (US 4,150,673) and further in view of Mason et al. (US 2002/0019608).
Richards in view of Watt discloses all the claimed subject matter as required except for the limitations as required in the claims 24-25.
Mason discloses an infusion pump comprising: a first cap 34 and a second cap 36 mates to surfaces on an infusion pump 12; wherein the first and second caps 34 & 36 comprises one or more feature elements providing dissimilar engagement interfaces for preventing mischanneling of the fluid.
Giving such a teaching by Mason, a person having ordinary skill in the art would have easily recognizes that modifying the in the device system of Richards in view of Watt with providing the first and second cap having different feature elements, i.e. different configurations (for example: one cap includes threads engagement, and the other provides a friction fit engagement, both of the caps have different shapes), as taught by Mason, for providing dissimilar engagement interface for the first and second reservoirs and manifolds and for preventing mischanneling of the fluid.
Therefore, the first reservoir comprises a feature that corresponded to a feature on the first cap so that the cap may mate with the first reservoir but not the second reservoir.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-8, 21-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783