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
Applicant has amended claims 1-4 and 6. Claim 3 was previously objected to for missing a period at the end of the sentence; the period has been added and thus this rejection is withdrawn.
Claim 11 has been cancelled.
Claims 12-16 have been added.
Claims 1-10 and 12-16 remain pending.
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 microvalves of claims 13-16 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6, 9-10, and 12-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cottin et al. (US 20210146037, henceforth Cottin).
Regarding claim 1, Cottin discloses an infusion system (system of fig. 1) for providing different medical fluids (multiple medical solutions of [0052]) to a patient (patient P, fig. 1), the infusion system comprising: a catheter (system of fig. 1 except for control device 2) comprising a catheter tube (single infusion line 102, fig. 2) and at least one lumen (single lumen as in [0056]) that extends longitudinally through the catheter tube (see [0056], it is understood that the single lumen extends longitudinally through single infusion line 102 as this is the only way for the fluid to travel through connection device 101 and out of a distal opening into the patient P for infusing the medical fluid) between a proximal tube end (connection device 101 is the proximal end of single infusion line 102, see fig. 2) and a distal tube end (the point at which infusion line 102 connects to a patient is a distal tube end as claimed); a plurality of micropump devices (infusion devices 10 with their respective delivery lines 100 and switchable valves, see figs. 1 and 2, and see [0053] and [0056], the infusion devices comprise peristaltic pumps, which are considered to be micropumps as the fingers of the peristaltic pumps are considered to be very small relative to rack 11 and Merriam Webster defines “micro” to mean “very small”; Examiner notes that infusion device 10E is a syringe infusion pump in the chosen embodiment, [0053]) mounted at the proximal tube end of the catheter (see figs. 1 and 2, the fingers of the peristaltic pumps 10 are connected to and mounted at connection device 101) whereby an outlet of each micropump device (see fig. 2, each infusion device 10 has an outlet which is a delivery line 100 which is part of each micropump device) debouches directly into the at least one lumen (see [0056], delivery lines 100 have valves at their distal ends in connection device 101; when a valve of a micropump device is opened and the device is configured for debouching, the delivery line 100 feeds directly into single infusion line 102; Examiner additionally notes that this is interpreted as being a functional limitation where the outlet of the micropump device is configured to debouch directly into the at least one lumen and not a positively recited method step of debouching, as a positive requirement of a step of debouching would be render the claim indefinite as claims cannot be drawn to both apparatuses and method steps) to convey fluid to the distal tube end (see [0052] and [0053]); and a control device (control device 2, fig. 1) connected to the plurality of micropump devices (see fig. 1, control device 2 is connected to system 1 via communication connection 20 as shown, see also [0055]), the control device being adapted to control the plurality of micropump devices (see [0057]-[0058]) so that the different medical fluids are deliverable through the at least one lumen by the plurality of micropump devices (see [0056]-[0058]) in a time division multiplex manner (see [0058]-[0059], the administration of medical solutions is multiplexed by multiplex module 22 across time).
Regarding claim 4, Cottin discloses the infusion system of claim 1 wherein the plurality of micropump devices are each adapted for intermittent delivery (see [0031], [0064], [0068], and [0071], fluids are delivered in packets which have pauses between them, and infusion devices 10 operate during delivery of the packets, meaning the infusion devices and micropumps within them are configured for intermittent delivery where the packets can be delivered and paused) with a cycle time of between 1 s and 100 s (see [0025] and [0026], durations can last for seconds, minutes, or hours, meaning that the cycles can be shorter than a minute, or less than 60 seconds, meaning that the cycles can be between 1 and 60 seconds which is within the claimed range), and wherein the control device is adapted to control the cycle time (see at least [0022] and [0024], the multiplex module 22 is what determines and controls the periods, or cycle times as claimed).
Regarding claim 5, Cottin discloses the infusion system of claim 4 wherein the control device is adapted to control the cycle time as a function of a predetermined overall delivery rate (see at least [0022]-[0024], the periods are determined in part based on the amount of time which each particular medical fluid can go without being delivered to maintain the desired total volume of each particular drug being delivered, where the overall volume of drug to be administered divided by the overall treatment time is a predetermined overall delivery rate as claimed).
Regarding claim 6, Cottin discloses the infusion system of claim 1 wherein the different medical fluids comprise a first medical fluid (drug A, fig. 7), a second medical fluid (drug C, fig. 7) and a third medical fluid (separator fluid, fig. 7), and wherein the plurality of micropump devices comprise a first micropump (peristaltic pump of infusion device 10A, fig. 1) for delivering the first medical fluid (it is understood that infusion device 10A is for delivering drug A as they have corresponding letters in their names), a second micropump (peristaltic pump of infusion device 10C, fig. 1) for delivering the second medical fluid (it is understood that infusion device 10C is for delivering drug C as they have corresponding letters in their names) and a third micropump (peristaltic pump of infusion device 10N, fig. 2) for delivering the third medical fluid (see [0069], separator fluid is delivered from dedicated infusion device 10N), the control device being adapted to control the first micropump, the second micropump and the third micropump ([0057]) so that first doses of the first medical fluid and second doses of the second medical fluid are deliverable through the at least one lumen in time division multiplex while being physically separated by the third medical fluid (see [0063], [0069], and fig. 7).
Regarding claim 9, Cottin discloses the infusion system of claim 1 wherein the catheter has a syringe adapter (since infusion device 10E is a syringe infusion pump in the chosen embodiment, it has a place for a syringe for the infusion, and thus it has a syringe adaptor which is the place for mounting the syringe for the syringe infusion pump).
Regarding claim 10, Cottin discloses the infusion system of claim 1 wherein the catheter is adapted as a disposable product for single use (this is a functional limitation requiring that the claimed catheter is capable of being used a single time and then disposed of; the called out catheter of claim 1 is physically capable of being used a single time and then disposed of as claimed, and thus this limitation is met), and the control device is adapted for multiple uses (see [0055] and [0057], the control device is a reusable device which can connect to the infusion devices for controlling them, and thus since it is taught to be a computing device such as a smart phone, it is understood to be capable of reuse as claimed by connecting to multiple instances of the system 1 as needed).
Regarding claim 12, Cottin discloses the infusion system of claim 1 wherein the plurality of micropump devices are integrated into the catheter (see fig. 1, the infusion devices 10 and their respective delivery lines 100 are integrated into the system of fig. 1 except for the control device 2 which is what is called out as the catheter in claim 1 above).
Regarding claim 13, Cottin discloses an infusion system (system of fig. 1) for providing different medical fluids (multiple medical solutions of [0052]) to a patient (patient P, fig. 1), the infusion system comprising: a catheter (system of fig. 1 except for control device 2) comprising a catheter tube (single infusion line 102, fig. 2) and at least one lumen (single lumen as in [0056]) that extends longitudinally through the catheter tube (see [0056], it is understood that the single lumen extends longitudinally through single infusion line 102 as this is the only way for the fluid to travel through connection device 101 and out of a distal opening into the patient P for infusing the medical fluid) between a proximal tube end (connection device 101 is the proximal end of single infusion line 102, see fig. 2) and a distal tube end (the point at which infusion line 102 connects to a patient is a distal tube end as claimed); a plurality of microvalves (switchable valves of [0056]) mounted at the proximal tube end of the catheter (see [0056] and fig. 2, the valves are located at the proximal end of single infusion line 102 which is the end shown in fig. 2 which is the end further from the patient) whereby an outlet of each microvalve debouches directly into the at least one lumen (see [0056], delivery lines 100 have valves at their distal ends in connection device 101; when a valve of a micropump device is opened and the device is configured for debouching, the delivery line 100 feeds directly into single infusion line 102) to convey fluid to the distal tube end (see [0052] and [0053]); and a control device (control device 2, fig. 1) connected to the plurality of microvalves (see fig. 1, control device 2 is connected to system 1 via communication connection 20 as shown, see also [0055]), the control device being adapted to control the plurality of microvalves (see [0057]-[0058]) so that the different medical fluids are deliverable through the at least one lumen by the plurality of microvalves (see [0056]-[0058]) in a time division multiplex manner (see [0058]-[0059], the administration of medical solutions is multiplexed by multiplex module 22 across time).
Regarding claim 14, Cottin discloses the infusion system of claim 13 wherein the plurality of microvalves are integrated into the catheter (see fig. 1, the infusion devices 10 and their respective delivery lines 100 are integrated into the system of fig. 1 except for the control device 2 which is what is called out as the catheter in claim 13 above).
Regarding claim 15, Cottin discloses a catheter (system of fig. 1 except for control device 2) comprising: a catheter tube (single infusion line 102, fig. 2) having at least one lumen (single lumen as in [0056]) that extends longitudinally through the catheter tube (see [0056], it is understood that the single lumen extends longitudinally through single infusion line 102 as this is the only way for the fluid to travel through connection device 101 and out of a distal opening into the patient P for infusing the medical fluid) between a proximal tube end (connection device 101 is the proximal end of single infusion line 102, see fig. 2) and a distal tube end (the point at which infusion line 102 connects to a patient is a distal tube end as claimed); and a plurality of micropump devices or microvalves (infusion devices 10, see figs. 1 and 2, and see [0053], the infusion devices comprise peristaltic pumps, which are considered to be micropumps as the fingers of the peristaltic pumps are considered to be very small relative to rack 11 and Merriam Webster defines “micro” to mean “very small”; Examiner notes that infusion device 10E is a syringe infusion pump in the chosen embodiment, [0053]) mounted at the proximal tube end of the catheter (see figs. 1 and 2, the fingers of the peristaltic pumps 10 are connected to and mounted at connection device 101) whereby an outlet of each micropump device (see fig. 2, each infusion device 10 has an outlet which is a delivery line 100 which is part of each micropump device) or microvalve debouches directly into the at least one lumen (see [0056], delivery lines 100 have valves at their distal ends in connection device 101; when a valve of a micropump device is opened and the device is configured for debouching, the delivery line 100 feeds directly into single infusion line 102) to convey fluid to the distal tube end (see [0052] and [0053]).
Regarding claim 16, Cottin discloses the catheter of claim 15 wherein the plurality of micropump devices or microvalves are integrated into the proximal tube end of the catheter tube (see fig. 1, the infusion devices 10 and their respective delivery lines 100 are integrated into the system of fig. 1 except for the control device 2 which is what is called out as the catheter in claim 15 above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottin et al. (US 20210146037, henceforth Cottin) as applied to claim 1 above.
Regarding claim 2, Cottin discloses the infusion system of claim 1 wherein the plurality of micropump devices are each adapted to deliver with a variable determined delivery rate (see [0031], [0032], [0079], delivery rates are determined by the controller depending on the listed factors), and wherein the control device is adapted to control the delivery rate (see [0079]-[0081]). Cottin also teaches that different medical fluids are known to be infused with different delivery rates depending on what the drug is and what the total desired volume of drug to be administered is ([001], [0079], [0081]), and that one of ordinary skill in the art is capable of determining the desired delivery flow rate ([0031]).
Cottin does not explicitly disclose that the delivery rate is between 0.05 ml/min to 500 ml/min as claimed. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted the plurality of micropumps to deliver the various medical fluids with delivery rates in the claimed range depending on the drug, the total volume of drug and fluid to be infused, the maximum allowed infusion delivery rate for that particular drug, and the total infusion duration which render the delivery rate from each particular infusion device to be a result effective variable which is determined based on the listed factors and optimization of a result effective variable is known to be within the level of one of ordinary skill in the art, and further that the optimization of the flow rate into the claimed range would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, Cottin discloses the infusion system of claim 2 wherein the control device is adapted to control the delivery rate as a function of a predetermined overall delivery rate (see [0031], [0079], [0081], the overall delivery rate is the total fluid volume to be administered and total fluid duration rate and the delivery rate for each infusion pump is determined partially in relation to this as claimed).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottin et al. (US 20210146037, henceforth Cottin) as applied to claim 6 above, and further in view of Schermeier et al. (US 20190336674, henceforth Schermeier, previously made of reference).
Regarding claim 7, Cottin discloses the infusion system of claim 6. Cottin additionally teaches that the micropumps, especially the first micropump, is a peristaltic pump ([0053]).
Cottin does not disclose the infusion system wherein at least the first micropump is adapted to reverse a delivery direction, and the control device is adapted to control the first micropump so that a first dose of the first medical fluid, provided into the at least one lumen, is partially aspirated from the at least one lumen by a reversal of the delivery direction. Schermeier teaches an infusion system (system of fig. 1) comprising micropumps equivalent to those of Cottin (peristaltic pumps as in [0025], which are deaeration device 3 in fig. 1) which are adapted to reverse a delivery direction (see [0025], peristaltic pumps are physically and functionally capable of reversing direction from a delivery direction to an aspiration direction), and a control device (control device 8, fig. 1) which is adapted to control the micropumps ([0118]) to partially aspirate doses of medical fluids (see [0025], air which is a first dose of a medical fluid as claimed is aspirated by the peristaltic pump prior to initiation of delivery from a reservoir where the aspiration involves priming a fluid channel by filling it with rinsing fluid) from a lumen (fluid channel of [0025]) by a reversal of the delivery direction (reversal as in [0025] where a first direction moves the air which is the claimed first dose towards the patient and reversal moves the air away from the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the first micropump and the control device to reverse the delivery direction such as to partially aspirate air from the lumen of the catheter infusion tube prior to use as in Schermeier for priming the system and for preventing air from being infused intravascularly into a patient (see Schermeier [0002], [0023]-[0025], and [0126]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottin et al. (US 20210146037, henceforth Cottin) as applied to claim 1 above, and further in view of O’Connor et al. (US Pat. No. 5545151, henceforth O’Connor), Unger (US 20030088176), and Okamura (US 20120323182).
Regarding claim 8, Cottin discloses the infusion system of claim 1 having a single lumen ([0056]).
Cottin does not disclose the infusion system wherein the at least one lumen comprises a first lumen having hydrophobic surface properties. O’Connor teaches a catheter (catheter 10, fig. 1) having an innermost lumen (inner layer 28, fig. 1) which has hydrophobic properties (see Col. 2 lines 58-61). O’Connor additionally teaches that hydrophobic materials will not absorb moisture or swell (see Col. 1 lines 36-40 and Col. 2 lines 58-61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the single tube of the catheter of Cottin out of materials with hydrophobic properties to prevent absorption of moisture and swelling as this maintains torqueability and prevents catheter kinking (see O’Connor Col. 1 lines 36-40).
Cottin as modified by O’Connor does not disclose the catheter comprising a second lumen having lipophobic surface properties. Unger teaches that a lipophobic material is a hydrophilic material ([0084]). Okamura teaches a catheter (introducer sheath of [0011]) having a lumen (the interior of the sheath of [0011] is a lumen) with a hydrophilic outer surface ([0007] and [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second lumen of Okamura to the outside of the first lumen of Cottin as modified as Okamura teaches that outer lumens with exterior surfaces which are hydrophilic provide beneficial sliding properties to lubricate the exterior of the catheter tube such as to remove the catheter tube smoothly (see Okamura [0007], [0011], [0015]). Such a modified device would then have a second lumen as claimed which extends radially around the exterior of the first lumen as claimed and would yield the benefit of slidability from the lipophobic (or hydrophilic, as taught by Unger) outer lumen and the benefit of the non-swelling, torqueable, kink resistant inner lumen.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Regarding the independent claims, Applicant has argued the Cottin does not disclose the claimed features, particularly the arrangement where the outlet of the micropump devices debouches directly into the at least one lumen. Examiner respectfully disagrees. The micropumps of Cottin can be considered to include the delivery lines and respective switchable valves for each of the infusion pumps 10 of Cottin, and thus the pump would be configured for debouching directly into the at least one lumen of the catheter tube as claimed under this alternative interpretation.
Applicant additionally argues regarding claims 7 and 8 that references Schermeier, O’Connor, Unger, and Okamura additionally do not disclose the claimed arrangement. This is not the assertion of the Examiner, and the new interpretation of Cottin relied upon above renders this argument moot.
The other independent claims are rejected for the reasons indicated above as well, especially under the new interpretation of Cottin.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783