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 .
Election/Restrictions
Applicant's election with traverse of Species I (Figures 1A-1B, 4) in the reply filed on January 22, 2026, is acknowledged.
The traversal is on the ground(s) that: Applicant traverses the Election of Species Requirement on the basis that Applicant is entitled to examination of a reasonable number of species (i.e., reasonable being more than 1) and that there would be no serious burden in conducting searches encompassing the full scope of Applicant's currently pending claims. The Election of Species Requirement contends that "[t]here is a serious search and/or examination burden for the patentably distinct species as set forth above because ... the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter, and/or [] the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or queries.)" See Election of Species Requirement, p. 3. However, the Election of Species Requirement does not provide any specific explanation as to the purported different classes/subclasses or electronic resources such that search of the full scope of the currently pending claims would amount to a serious search and/or examination burden on the examiner. See MPEP §808.02 (requiring that the examiner must show by appropriate explanation one of the following: (A) separate classification thereof, (B) a separate status in the art when they are classifiable together, and (C) a different field of search). Therefore, Applicant respectfully submits that the Election of Species Requirement does not provide an explanation sufficient to meet the requirements described for establishing a serious search burden, as required by MIPEP § 808.02 (Remarks, pages 13-14).
This is not found persuasive because: The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. Species I (Figures 1A-1B, 4) at least claims a third connector, a first pressure relief valve, a second pressure relief valve, a third pressure relief valve, a fourth pressure relief valve, and a secondary connector. Species II (Figures 5-6C) at least claims a chamber with an inlet port. Species III (Figure 7) at least claims a restrictor orifice of fixed size. In addition, these species are not obvious variants of each other based on the current record. There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). At minimum, the mutually exclusive characteristics of such species recited in the claims amount to divergent subject matter requiring different search strategies or search queries.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-18, 31-36, and 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Species II-III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 22, 2026.
Currently, claims 1-12, 19-30, 37-40, and 43-50 are under examination as encompassing elected Species I (Figures 1A-1B, 4).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “308” has been used to designate both hub and occluder. 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. 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.
Specification
The abstract of the disclosure is objected to because:
In line 1, “method” should be changed to “a method”
In line 8, “the infusion catheter” should be changed to “the at least one infusion catheter”
In line 9, “the infusion catheter” should be changed to “the at least one infusion catheter”
In line 9, “the vascular system” should be changed to “a vascular system”
In line 12, “the infusion catheter” should be changed to “the at least one infusion catheter”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-4, 6-8, 10, 12, 19-22, 24-26, 28, 30, 37, 43, 46-48, and 50 are objected to because of the following informalities:
In regards to claim 1, line 9, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 1, line 9, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 1, line 10, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 1, line 10, “the vascular system” should be changed to “a vascular system”.
In regards to claim 2, lines 3-4, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 2, line 4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 3, line 3, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 3, lines 4-5, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 4, lines 4-5, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 6, line 2, “the first and third pressure relief valves” should be changed to “the first pressure relief valve and the third pressure relief valve”.
In regards to claim 6, line 4, “the second and fourth pressure relief valves” should be changed to “the second pressure relief valve and the fourth pressure relief valve”.
In regards to claim 7, line 2, “the first and second pressure relief valves” should be changed to “the first pressure relief valve and the second pressure relief valve”.
In regards to claim 7, line 3, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 7, line 4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 7, line 5, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 7, line 6, “the third and fourth pressure relief valves” should be changed to “the third pressure relief valve and the fourth pressure relief valve”.
In regards to claim 7, lines 7-8, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 7, line 8, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 7, line 9, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 8, lines 2-3, “the first, second, third, and fourth pressure relief valves” should be changed to “the first pressure relief valve, the second pressure relief valve, the third pressure relief valve, and the fourth pressure relief valve”.
In regards to claim 10, line 3, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 10, lines 4-5, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 10, line 6, “the least one further manual syringe pump” should be changed to “the at least one further manual syringe pump”.
In regards to claim 12, line 3, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 12, lines 3-4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 12, line 6, “the least one further manual syringe pump” should be changed to “the at least one further manual syringe pump”.
In regards to claim 12, line 7, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 19, line 1, “a patient, comprising:” should be changed to “a patient, the system comprising:”.
In regards to claim 19, line 2, “a patient” should be changed to “the patient”.
In regards to claim 19, lines 9-10, “the flow rate” should be changed to “a flow rate”.
In regards to claim 19, lines 10-11, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 19, line 11, the first recitation of “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 19, line 11, the second recitation of “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 19, line 11, “the vascular system” should be changed to “a vascular system”.
In regards to claim 20, line 3, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 20, line 4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 21, line 3, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 21, lines 4-5, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 22, lines 4-5, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 24, lines 2-3, “the first, second, third, and fourth pressure relief valves” should be changed to “the first pressure relief valve, the second pressure relief valve, the third pressure relief valve, and the fourth pressure relief valve”.
In regards to claim 25, line 2, “the first and third pressure relief valves” should be changed to “the first pressure relief valve and the third pressure relief valve”.
In regards to claim 25, line 4, “the second and fourth pressure relief valves” should be changed to “the second pressure relief valve and the fourth pressure relief valve”.
In regards to claim 26, line 2, “the first and second pressure relief valves” should be changed to “the first pressure relief valve and the second pressure relief valve”.
In regards to claim 26, line 3, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 26, line 4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 26, line 5, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 26, line 6, “the third and fourth pressure relief valves” should be changed to “the third pressure relief valve and the fourth pressure relief valve”.
In regards to claim 26, line 7, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 26, line 8, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 26, line 9, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 28, line 3, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 28, lines 4-5, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 28, line 6, “the least one further manual syringe pump” should be changed to “the at least one further manual syringe pump”.
In regards to claim 30, line 3, “the least one manual syringe pump” should be changed to “the at least one manual syringe pump”.
In regards to claim 30, lines 3-4, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 30, line 6, “the least one further manual syringe pump” should be changed to “the at least one further manual syringe pump”.
In regards to claim 30, line 7, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 37, line 2, “the infusion catheter” should be changed to “the at least one infusion catheter”.
In regards to claim 37, line 2, “its distal end” should be changed to “the distal end”.
In regards to claim 43, line 1, “a patient, comprising:” should be changed to “a patient, the method comprising:”.
In regards to claim 43, line 15, “the vascular system” should be changed to “a vascular system”.
In regards to claim 46, lines 4-5, “the least one additional manual syringe pump” should be changed to “the at least one additional manual syringe pump”.
In regards to claim 47, line 2, “the first and third pressure relief valves” should be changed to “the first pressure relief valve and the third pressure relief valve”.
In regards to claim 47, line 3, “a desired rate” should be changed to “the desired rate”.
In regards to claim 47, line 4, “the second and fourth pressure relief valves” should be changed to “the second pressure relief valve and the fourth pressure relief valve”.
In regards to claim 48, line 2, “the first and second pressure relief valves” should be changed to “the first pressure relief valve and the second pressure relief valve”.
In regards to claim 48, lines 2-3, “a therapeutic agent” should be changed to “the therapeutic agent”.
In regards to claim 48, line 3, “manual pumping” should be changed to “the manual pumping”.
In regards to claim 48, line 3, “the first syringe pump” should be changed to “the first manual syringe pump”.
In regards to claim 48, line 6, “the third and fourth pressure relief valves” should be changed to “the third pressure relief valve and the fourth pressure relief valve”.
In regards to claim 48, lines 6-7, “a therapeutic agent” should be changed to “the therapeutic agent”.
In regards to claim 50, line 3, “manual pumping” should be changed to “the manual pumping”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 43-50 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 regards to claim 43, line 11 recites “a first manual syringe pump”. Claim 43, line 6 previously recites “at least one manual syringe pump”. It is unclear whether the two recitations are the same component or different components. Claims 44-50 are rejected by virtue of being dependent upon claim 43.
In regards to claim 44, line 2 recites “a therapeutic agent”. Claim 44 depends upon claim 43. Claim 43, line 12 previously recites “fluid”. It is unclear whether the two recitations are the same component or different components. Claims 45-48 are rejected by virtue of being dependent upon claim 44.
In regards to claim 49, line 6 recites “a secondary manual syringe pump”. Claim 49, line 3 previously recites “at least one further manual syringe pump”. It is unclear whether the two recitations are the same component or different components. Claim 50 is rejected by virtue of being dependent upon claim 49.
In regards to claim 50, line 2 recites “a therapeutic agent”. Claim 50 depends upon claim 49, which depends upon claim 43. Claim 43, line 12 previously recites “fluid”. It is unclear whether the two recitations are the same component or different components.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 19-22, 40, and 43-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burns et al (US 2016/0106915).
In regards to claim 1, Burns et al teaches a device (Figures 6A-6C, device 55) for use with at least one infusion catheter for treatment of a patient, wherein the at least one infusion catheter has a proximal end with a hub, a distal end with a distal tip, and a lumen extending from the proximal end to the distal tip, the device comprising:
a connector body (60) having a first connector (58a) for fluidly coupling and detachably connecting to the hub of the at least one infusion catheter (Figure 6C), a second connector (56a) for fluidly coupling and detachably connecting to at least one manual syringe pump (Figure 6C), and a passive pressure-controlled mechanical flow regulator (64/66/68) that regulates fluid flow supplied by manual pump action of the least one manual syringe pump to the infusion catheter and delivered by the infusion catheter into the vascular system of the patient (Figures 6A-6C)
In regards to claim 2, Burns et al teaches wherein: the passive pressure-controlled mechanical flow regulator is configured to deliver a therapeutic agent or a secondary fluid supplied under pressure by pumping action of the least one manual syringe pump into and through the lumen of the infusion catheter at a desired rate of infusion (Figures 6A-6C).
In regards to claim 3, Burns et al teaches wherein: the connector body further includes a first flowpath (of 58a) that extends through the first connector and is fluidly coupled to the lumen of the infusion catheter during use (Figure 6C) and a second flowpath (of 56a) that extends through the second connector and is fluidly coupled to the least one manual syringe pump during use (Figure 6C), wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to both the first flowpath and the second flowpath (Figures 6A-6C).
In regards to claim 4, Burns et al teaches wherein: the connector body further includes a third connector (58b) for fluidly coupling and detachably connecting to at least one additional manual syringe pump and a third flowpath (of 58b) that extends through the third connector and is fluidly coupled to the least one additional manual syringe pump during use, wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to the third flowpath (Figure 6B).
In regards to claim 19, Burns et al teaches a system (Figures 6A-6C) for treating a patient, comprising:
at least one infusion catheter (12/14) for treatment of a patient, wherein the at least one infusion catheter has a proximal end with a hub (28), a distal end with a distal tip (Figure 3B), and a lumen extending from the hub to the distal tip through which to infuse a first fluid into the patient (Figures 6C, 3B)
at least one connector body (60) having a first connector (58a) for fluidly coupling and detachably connecting to the hub of the at least one infusion catheter (Figure 6C), a second connector (56a) for fluidly coupling and detachably connecting to at least one manual syringe pump containing the first fluid (Figure 6C), and a passive pressure-controlled mechanical flow regulator (64/66/68) that regulates the flow rate of the first fluid supplied by manual pump action of the least one manual syringe pump to the infusion catheter and delivered by the infusion catheter into the vascular system of the patient (Figures 6A-6C, 3B)
In regards to claim 20, Burns et al teaches wherein: the passive pressure-controlled mechanical flow regulator is configured to deliver the first fluid supplied under pressure by pumping action of the least one manual syringe pump into and through the lumen of the infusion catheter at a desired rate of infusion (Figures 6A-6C).
In regards to claim 21, Burns et al teaches wherein: the connector body further includes a first flowpath (of 58a) that extends through the first connector and is fluidly coupled to the lumen of the infusion catheter during use (Figure 6C) and a second flowpath (of 56a) that extends through the second connector and is fluidly coupled to the least one manual syringe pump during use (Figure 6C), wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to both the first flowpath and the second flowpath (Figures 6A-6C).
In regards to claim 22, Burns et al teaches wherein: the connector body further includes a third connector (58b) for fluidly coupling and detachably connecting to at least one additional manual syringe pump and a third flowpath (of 58b) that extends through the third connector and is fluidly coupled to the least one additional manual syringe pump during use, wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to the third flowpath (Figure 6B).
In regards to claim 40, Burns et al teaches wherein: the first fluid is a therapeutic agent or a secondary fluid (paragraph [0075]).
In regards to claim 43, Burns et al teaches a method of treating a patient, comprising:
providing a system (Figures 6A-6C) including an infusion catheter (12/14) and a connector body (60), the infusion catheter having a proximal end with a hub (28), a distal end with a distal tip (Figure 3B), and a lumen extending from the proximal end to the distal tip (Figures 6C, 3B), the connector body having a first connector (58a) for fluidly coupling and detachably connecting to the hub of the infusion catheter (Figure 6C), a second connector (56a) for fluidly coupling and detachably connecting to at least one manual syringe pump (Figure 6C), and a passive pressure-controlled mechanical flow regulator (64/66/68)
fluidly coupling and detachably connecting the first connector of the connector body to the hub of the infusion catheter (Figure 6C)
fluidly coupling and detachably connecting the second connector of the connector body to a first manual syringe pump (40) (Figure 6C)
manually pumping the first manual syringe pump to pump fluid into the infusion catheter (paragraph [0088]), wherein the passive pressure-controlled mechanical flow regulator of the connector body regulates fluid flow into and through the infusion catheter for delivery by the infusion catheter into the vascular system of the patient (Figures 6A-6C, 3B)
In regards to claim 44, Burns et al teaches wherein: the connector body is configured to deliver a therapeutic agent into and through the lumen of the infusion catheter at a desired rate of infusion, wherein the therapeutic agent is supplied to the connector body under pressure by the manual pumping of the first manual syringe pump (paragraph [0088])(Figures 6A-6C, 3B).
In regards to claim 45, Burns et al teaches wherein: the connector body further includes a first flowpath (of 58a) that extends through the first connector and is fluidly coupled to the lumen of the infusion catheter during use (Figure 6C) and a second flowpath (of 56a) that extends through the second connector and is fluidly coupled to the first manual syringe pump during use (Figure 6C), wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to both the first flowpath and the second flowpath (Figures 6A-6C).
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.
Claims 9-12, 27-30, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al, as applied to claims 1, 19, and 43 above, and further in view of Lin (US 10,953,151).
In regards to claim 9, Burns et al does not teach wherein: the connector body further includes a secondary connector for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses the passive pressure-controlled mechanical flow regulator. Lin teaches a device (Figure 17, device 10) wherein: a connector body (20) further includes a secondary connector (50) for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses a passive pressure-controlled mechanical flow regulator (30/36/34/120) (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the device of Burns et al, to further include a secondary connector, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 10, in the modified device of Burns et al and Lin, Burns et al teaches wherein: the connector body further includes a first flowpath (of 58a) that extends through the first connector and is fluidly coupled to the lumen of the infusion catheter during use (Figure 6C), a second flowpath (of 56a) that extends through the second connector and is fluidly coupled to the least one manual syringe pump during use (Figure 6C), wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to both the first flowpath and the second flowpath (Figures 6A-6C). However, Burns et al does not teach an additional flowpath that extends through the secondary connector and is fluidly coupled to the least one further manual syringe pump during use, and the additional flowpath is fluidly coupled to the second flowpath downstream of the passive pressure-controlled mechanical flow regulator. Lin teaches an additional flowpath (90) that extends through the secondary connector and is fluidly coupled to the least one further manual syringe pump during use (Figure 17), and the additional flowpath is fluidly coupled to a second flowpath (of 160) downstream of the passive pressure-controlled mechanical flow regulator (Figure 17 with fill port 160 of Figure 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified device of Burns et al and Lin, to further include an additional flowpath, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 11, in the modified device of Burns et al and Lin, Burns et al does not teach wherein: the connector body further includes a check valve disposed between the passive pressure-controlled mechanical flow regulator and the additional flowpath. Lin teaches wherein: the connector body further includes a check valve (110) disposed between the passive pressure-controlled mechanical flow regulator and the additional flowpath (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified device of Burns et al and Lin, to further include a check valve, as taught by Lin, as such will close and block the extra bolus dose of fluid from going past the check valve and down the wrong fluid path in the device, e.g., toward the reservoir of the passive pressure-controlled mechanical flow regulator (column 9, lines 43-47).
In regards to claim 12, in the modified device of Burns et al and Lin, Burns et al teaches wherein: the connector body is configured to deliver a therapeutic agent supplied under pressure by pumping action of the least one manual syringe pump into and through the lumen of the infusion catheter at a desired rate of infusion (Figure 6C). However, Burns et al does not teach the connector body is further configured to deliver a secondary fluid supplied under pressure by pumping action of the least one further manual syringe pump into and through the lumen of the infusion catheter. Lin teaches the connector body is further configured to deliver a secondary fluid supplied under pressure by pumping action of the least one further manual syringe pump into and through a lumen of an infusion catheter (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified device of Burns et al and Lin, to be further configured to deliver a secondary fluid, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 27, Burns et al does not teach wherein: the connector body further includes a secondary connector for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses the passive pressure-controlled mechanical flow regulator. Lin teaches a system (Figure 17) wherein: a connector body (20) further includes a secondary connector (50) for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses a passive pressure-controlled mechanical flow regulator (30/36/34/120) (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the system of Burns et al, to further include a secondary connector, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 28, in the modified system of Burns et al and Lin, Burns et al teaches wherein: the connector body further includes a first flowpath (of 58a) that extends through the first connector and is fluidly coupled to the lumen of the infusion catheter during use (Figure 6C), a second flowpath (of 56a) that extends through the second connector and is fluidly coupled to the least one manual syringe pump during use (Figure 6C), wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to both the first flowpath and the second flowpath (Figures 6A-6C). However, Burns et al does not teach an additional flowpath that extends through the secondary connector and is fluidly coupled to the least one further manual syringe pump during use, and the additional flowpath is fluidly coupled to the second flowpath downstream of the passive pressure-controlled mechanical flow regulator. Lin teaches an additional flowpath (90) that extends through the secondary connector and is fluidly coupled to the least one further manual syringe pump during use (Figure 17), and the additional flowpath is fluidly coupled to a second flowpath (of 160) downstream of the passive pressure-controlled mechanical flow regulator (Figure 17 with fill port 160 of Figure 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified system of Burns et al and Lin, to further include an additional flowpath, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 29, in the modified system of Burns et al and Lin, Burns et al does not teach wherein: the connector body further includes a check valve disposed between the passive pressure-controlled mechanical flow regulator and the additional flowpath. Lin teaches wherein: the connector body further includes a check valve (110) disposed between the passive pressure-controlled mechanical flow regulator and the additional flowpath (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified system of Burns et al and Lin, to further include a check valve, as taught by Lin, as such will close and block the extra bolus dose of fluid from going past the check valve and down the wrong fluid path in the device, e.g., toward the reservoir of the passive pressure-controlled mechanical flow regulator (column 9, lines 43-47).
In regards to claim 30, in the modified system of Burns et al and Lin, Burns et al teaches wherein: the connector body is configured to deliver the first fluid supplied under pressure by pumping action of the least one manual syringe pump into and through the lumen of the infusion catheter at a desired rate of infusion (Figure 6C). However, Burns et al does not teach the connector body is further configured to deliver a secondary fluid supplied under pressure by pumping action of the least one further manual syringe pump into and through the lumen of the infusion catheter. Lin teaches the connector body is further configured to deliver a secondary fluid supplied under pressure by pumping action of the least one further manual syringe pump into and through a lumen of an infusion catheter (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified system of Burns et al and Lin, to be further configured to deliver a secondary fluid, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 49, Burns et al does not teach wherein: the connector body further includes a secondary connector for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses the passive pressure-controlled mechanical flow regulator; and the method further includes fluidly coupling and detachably connecting the secondary connector of the connector body to a secondary manual syringe pump. Lin teaches a method, wherein: a connector body (20) further includes a secondary connector (50) for fluidly coupling and detachably connecting to at least one further manual syringe pump in a configuration that bypasses a passive pressure-controlled mechanical flow regulator (30/36/34/120) (Figure 17); and the method further includes fluidly coupling and detachably connecting the secondary connector of the connector body to a secondary manual syringe pump (14) (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the method of Burns et al, to further include a secondary connector, and fluidly coupling and detachably connecting the secondary connector of the connector body to a secondary manual syringe pump, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
In regards to claim 50, in the modified method of Burns et al and Lin, Burns et al teaches wherein: the connector body is configured to deliver a therapeutic agent supplied under pressure by manual pumping of the first manual syringe pump into and through the lumen of the infusion catheter at a desired rate of infusion (Figure 6C). However, Burns et al does not teach the connector body is further configured to deliver a secondary fluid supplied under pressure by manual pumping of the secondary manual syringe pump into and through the lumen of the infusion catheter. Lin teaches the connector body is further configured to deliver a secondary fluid supplied under pressure by manual pumping of the secondary manual syringe pump into and through a lumen of an infusion catheter (Figure 17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector body, of the modified method of Burns et al and Lin, to be further configured to deliver a secondary fluid, as taught by Lin, as such will allow for administering a bolus injection (column 12, lines 9-16) as an optional extra dose of fluid (Abstract) for treating various medical conditions (column 1, lines 20-23).
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al, as applied to claim 19 above, and further in view of Chomas et al (US 2012/0116351).
In regards to claim 37, Burns et al does not teach wherein: the infusion catheter includes an occluder at its distal end adapted to prevent reflux of the first fluid. Burns et al instead teaches wherein: the infusion catheter includes a stent (16) at its distal end (Figure 3B). Chomas et al teaches a system (Figures 34-36) wherein: an infusion catheter (2401/2404) includes an occluder (2412) at its distal end adapted to prevent reflux of a first fluid (Figure 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion catheter, of the system of Burns et al, to include an occluder, as taught by Chomas et al, as such will prevent reverse flow of the first fluid past the occluder (paragraph [0122]) in order to reduce reflux of the first fluid into non-targeted vessels (paragraph [0003]).
In regards to claim 38, in the modified system of Burns et al and Chomas et al, Burns et al does not teach wherein: the occluder is a dynamic occluder. Chomas et al teaches wherein: the occluder is a dynamic occluder (2412). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the occluder, of the modified system of Burns et al and Chomas et al, to be a dynamic occluder, as taught by Chomas et al, as such will prevent reverse flow of the first fluid past the occluder (paragraph [0122]) in order to reduce reflux of the first fluid into non-targeted vessels (paragraph [0003]).
In regards to claim 39, in the modified system of Burns et al and Chomas et al, Burns et al does not teach wherein: the dynamic occluder is a microvalve. Chomas et al teaches wherein: the dynamic occluder is a microvalve (2412)(Title: Microvalve). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the dynamic occluder, of the modified system of Burns et al and Chomas et al, to be a microvalve, as taught by Chomas et al, as such will prevent reverse flow of the first fluid past the occluder (paragraph [0122]) in order to reduce reflux of the first fluid into non-targeted vessels (paragraph [0003]).
Allowable Subject Matter
Claims 5-8 and 23-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 5, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a device for use with at least one infusion catheter for treatment of a patient, as claimed, specifically including wherein: the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath.
Burns et al does not teach wherein: the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath. Burns et al instead teaches wherein: the passive pressure-controlled mechanical flow regulator (64/66/68) includes a chamber (64), a plunger (66), and a spring (68) (Figures 6A-6C).
Thus, claim 5 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claims 3-4. Claims 6-8 are objected to by virtue of being dependent upon claim 5.
In regards to claim 23, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a system for treating a patient, as claimed, specifically including wherein: the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath.
Burns et al does not teach wherein: the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath. Burns et al instead teaches wherein: the passive pressure-controlled mechanical flow regulator (64/66/68) includes a chamber (64), a plunger (66), and a spring (68) (Figures 6A-6C).
Thus, claim 23 is objected to as being dependent upon a rejected base claim 19, but would be allowable if rewritten in independent form including all of the limitations of the base claim 19 and intervening claims 21-22. Claims 24-26 are objected to by virtue of being dependent upon claim 19.
Claims 46-48 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
In regards to claim 46, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method of treating a patient, as claimed, specifically including the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath; and the method further includes fluidly coupling and detachably connecting the third connector of the connector body to a second manual syringe pump separate and distinct from the first manual syringe pump.
Burns et al teaches wherein: the connector body further includes a third connector (58b) for fluidly coupling and detachably connecting to at least one additional manual syringe pump and a third flowpath (of 58b) that extends through the third connector and is fluidly coupled to the least one additional manual syringe pump during use, wherein the passive pressure-controlled mechanical flow regulator is fluidly coupled to the third flowpath (Figure 6B).
Burns et al does not teach the passive pressure-controlled mechanical flow regulator includes i) a first pressure relief valve having an inlet fluidly coupled to the second flowpath and an outlet fluidly coupled to the first flowpath; ii) a second pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the third flowpath; iii) a third pressure relief valve having an inlet fluidly coupled to the third flowpath and an outlet fluidly coupled to the first flowpath; and iv) a fourth pressure relief valve having an inlet fluidly coupled to the first flowpath and an outlet fluidly coupled to the second flowpath; and the method further includes fluidly coupling and detachably connecting the third connector of the connector body to a second manual syringe pump separate and distinct from the first manual syringe pump. Burns et al instead teaches the passive pressure-controlled mechanical flow regulator (64/66/68) includes a chamber (64), a plunger (66), and a spring (68) (Figures 6A-6C), and the method further includes the third connector (58b) releasing excessive agent out of the system (Figure 6B)(paragraph [0102]).
Thus, claim 46 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim 43 and intervening claims 44-45. Claims 47-48 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, by virtue of being dependent upon claim 46.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783