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 and Request for Continued Examination (RCE) filed on 06/12/26 have been entered in the case. Claims 2-8, 21-25 are pending for examination and claims 1, 9-20 are cancelled.
Corrected Election/Restrictions
Examiner would like to make the correction in the Requirement for Restriction/Election 10/11/24 as below: The Requirement for Restriction/Election 10/11/24 omitted the sub-species 1d-1f in the species of Figs. 1-2. It is noted that the Figs. 7A-8C illustrate the different types of feature elements that used in connection with the outlet ports of the infusion pump of the infusion pump system of Fig. 1, see paras [0038-0039] in the original specification of the current application.
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Applicant filed a response to Election/Restriction on 11/08/24. Applicant states on page 2 of the Election/Restriction 11/08/24 that:
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Applicant states on page 6 in the Remarks 06/12/26 that both figures 4 & 7A were elected in an ambiguous restriction requirement make only with vague references to figures with no explanation as to what specific elements in the figures were requiring species election.
In response, the Applicant elected species 2 (Fig. 4) and then elected sub-species Fig. 7A. Although figures 7A-8C were omitted in the original Restriction/Election Requirement 10/11/24, the Applicant should note that these omitted figures 7A-8C do not belong to the species 2 (Fig. 4). Since the species 1 (Figs. 1-2) elected, the Applicant should not (or cannot) elect any of the omitted figures 7A-8C, but rather should elect one of the sub-species 2a (Figs. 5A-5C), or 2b (Figs 6A-6C) or 2c (Fig. 6) falling under the category of the species 1 (Figs. 1-2).
The Applicant is well aware of the nature of the invention. However, the Applicant intentionally made an election spanning two distinct embodiments (Fig. 4; and wherein the sub-species Fig 7A belongs to non-elected species Fig. 1). The multiplicity of species and sub-species that an unduly extensive and burdensome search would be necessary to search the entire scope of the claim. It is unreasonable to expect the Examiner to examine multiple distinct embodiments within the allotted time frame.
If Applicant wishes to elect species of Fig. 4, then Applicant must elect one of the sub-species 2a (Figs. 5A-5C), or 2b (Figs 6A-6C) or 2c (Fig. 6).
If Applicant wishes to elect species of Fig. 1, then Applicant must elect one of the sub-species 1a) Figs. 3A-3C or 1b) Fig 3D, or 1c) Fig 3E.
Applicant is required to elect a single species and sub-species is elected that must be falling under chosen species group for examination. In addition, the claim(s) should be amended within the elected species & sub-species for examining.
Appropriate correction is required by Applicant in the next responsive.
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.
The limitation, i.e., the feature elements of the first and second ports of the infusion pump are positioned, respectively, on first and second caps..., in claim 2 is failing to comply with the written description requirement.
The Fig. 4 shows that the first and second caps 68 & 78 are located on (or outside) of the first and second ports 64 & 72. In other words, the first and second caps 68 & 78 are located on the first and second ports 64 & 72, respectively.
Other claims 2-8 & 21-25 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 2-8, 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.
Claim 2 requires that: first and second ports 102/104; first and second tube each having an inlet port 114/116. It appears to Examiner that these mentioned elements are in the infusion pump in one of the Figs. 7A-7C; however, the claimed invention further requires that the feature elements of the first and second ports of the infusion pump are positioned, respective, on first and second caps configured to engage with the first and second ports of the pump. It is unclear to Examiner that how are the first and second caps being provided in the Figs. 7A-7C. Which elements are considered as the first and second caps in Figs. 7A-7C.
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The Fig. 4 shows the first and second caps 68/78 but does not show the first and second ports 64/72 are being connected to the multi-channel lumen.
Claims 3-8, 21-25 are being rejected due to their dependency.
In claim 21, the Fig. 4 shows that elements 14A/14B are designated to first and second manifolds. Based on the marked-up Fig. 4, it appears to the Examiner that the #14A/14B show a neck of the first and second reservoirs 16A/16B. For example: the Figs. 5A-5C shows the inlet port 64 and the cap 68 are engaged but does not include the manifold. Examiner finds difficult time to recognize the first and second manifolds.
Therefore, it is unclear to Examiner that the first and second manifolds are being referred to the neck of the reservoirs or the first and second manifolds being provided different features/structures. In that case, Applicant is requested to provide the drawing that clearly showing the first and second manifolds.
The claims 22-24 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.
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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, 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 describes a coded configuration mating connector system designed to prevent medical errors in fluid delivery apparatus, such as intravenous lines. Therefore, the matching coded configuration/shape indicators on mating components (inlet-outlet shape code fitment) to ensure secure, correct connections. Watt discloses a color-coded mating 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 to prevent medical errors in fluid delivery apparatus, 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 filed 06/12/26 have been fully considered but they are not persuasive.
Applicant argues that Richards reports a medication dispensing device that mounts reservoirs that can be different sized and shaped. Watt reports a bag for storage blood component with removable protective caps (with no openings), does not have any port. None of references teach or suggest the caps as defined in the amended claims.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Richards discloses a protective cap (1/2 circle-shaped) is positioned on the port 22/24 of infusion pump, see similar the marked-up figures below. Richards does not disclose that the inlet port of the first and second tubes each having feature element that different to each other.
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Meanwhile, Watt describes a coded configuration mating connector system designed to prevent medical errors in fluid delivery apparatus, such as intravenous lines. Therefore, the matching coded configuration/shape indicators on mating components (inlet-outlet shape code fitment) to ensure secure, correct connections. Watt discloses multiple ports 8a-8e each having a feature element, i.e., lip portion 9a-9e in coded/shaped configuration to match with a feature element, i.e., lip portion 11a-11e of the inlet port of the tube to prevent mishandling in between the different type of blood components.
Giving such a teaching by Watt, a person skilled in the art would recognize that the first and second ports of the pumps are being provided in different feature, i.e., shape or configuration; and the inlet port of the first and second tube each having different feature, i.e., shape or configuration; wherein the feature element in the inlet port of the first tube must be compatible with the first port of the pump; and the feature element in the inlet port of the second tube must be compatible with the second port of the pump, so that preventing inadvertent connection of the tube to an incorrect source of fluid.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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