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 .
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 1, 2, 11-15 and 17 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.
Regarding amended claim 1, the new limitation of “wherein the flow control device includes a filter, and wherein, the filter prevents the medicinal agent from flowing from the storage part into the first channel by providing a flow resistance” is not supported by the original disclosure and is considered new matter. The specification and drawings provide no detail of a “flow resistance” by the filter.
Claims 2, 11-15 and 17 are rejected by virtue of their dependency on claim 1.
Regarding amended claim 2, the new limitation of “the second state, the filter allows the medicinal agent to flow from the storage part into the first channel when a pressure is applied to the medicinal agent storage device” is not supported by the original disclosure and is considered new matter. The specification and drawings provide no detail of “a pressure” being applied to the medicinal agent storage device.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 11, 12 13, 14, 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shick et al. (US 20130264266 A1, herein Shick), and further in view of Thorne Jr. et al. (US 10434236 B2, herein Thorne Jr.).
Regarding claim 1, Shick disclosed a medical device (10 in combination with 21 and 51 in Fig. 3), comprising:
a catheter having a first channel (tubing 51 in Fig. 3; The outlet portion 14 includes a luer taper 50 in fluid communication with a central outlet port 52. The luer taper 50 includes an outer shape, a lumen therethrough, and is configured to form a fluidic coupling with a tubing 51 [0040]); and
a medicinal agent storage device (21 in Fig. 3) connected to the catheter, wherein the medicinal agent storage device includes a storage part and a second channel, wherein the storage part is configured to store a medicinal agent (It is set forth by Shick in [0032] that luer lock 20 is in connection with syringe 21 or other similar fluid supply device, both of which can be interpreted to have a storage part) and wherein the second channel provides fluid communication between the storage part and the first channel (the inlet portion 12 may include luer lock 20 that is configured to form a fluid tight connection with a syringe 21, a tube, or other similar fluid supply device [0032];
a flow control device (syringe filter 10 in Fig. 3); and
wherein, in a first state, the flow control device is configured to prevent the medicinal agent from flowing from the storage part into the first channel (the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter [0057]; it can be interpreted that the pressure capacity of the filter prevents flowing of medicinal agent, which can be interpreted as first state), and
wherein the flow control device is included in the catheter or included in the medicinal agent storage device [filter 10 connected to tubing 51 in Fig. 3].
wherein the flow control device includes a filter (syringe filter 10 in Fig. 3), and
wherein, in the first state, the filter prevents the medicinal agent from flowing from the storage part into the first channel by providing a flow resistance (the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter [0057]; it can be interpreted that the filter withstands a pressure before this pressure capacity is overcome by fluid flow, thus providing resistance to flow).
However, Shick failed to explicitly disclose a package enclosing the catheter, the medicinal agent storage device, and the flow control device in a sterilized state.
Thorne Jr. however teaches a unitized part 240 and a cap 250 are disposed and sealed within a sterilizable peel pouch or wrap 260 (sterilizable peel pouch 260 in Fig. 13) wherein contained parts are processed by gamma radiation, ethylene oxide or other sterilization process [0129].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the medical device of Shick with Thorne Jr. to include a package enclosing the catheter, the medicinal agent storage device, and the flow control device in a sterilized state since such a modification may maintain a sanitized state for the device. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 2, Shick as modified by Thorne Jr. disclosed all limitations of claim 1. Shick further disclosed wherein the flow control device is switchable between the first state and a second state (the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter [0057]; it can be interpreted that the pressure capacity of the filter prevents flowing of medicinal agent, which can be interpreted as first state, and once the pressure capacity is overcome to allow medicinal agent to flow, it can be interpreted as second state),
wherein, in the first state, the filter prevents the medicinal agent from flowing from the storage part into the first channel by providing the flow resistance (the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter [0057]; it can be interpreted that the filter withstands a pressure before this pressure capacity is overcome by fluid flow, thus providing resistance to flow), and
wherein, in the second state, the filter allows the medicinal agent to flow from the storage part into the first channel when a pressure is applied to the medicinal agent storage device ( the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter [0057]; it can be interpreted that the pressure capacity of filter is overcome by fluid to move between syringe 21 and tubing 51).
Regarding claim 11, Shick as modified by Thorne Jr. disclosed all limitations of claim 1. Shick failed to explicitly disclose further comprising the medicinal agent, wherein the medicinal agent is contained in the storage part.
However, Thorne Jr. teaches as a medical procedure associated with the instant invention involves, as a first step, delivering a dose from a syringe dedicated to providing a medication into a catheter port [0115].
Thorne Jr. further teaches medication or drug is drawn into syringe 20 in direction of arrow 300 by retracting plunger rod 66 in direction of arrow 302. [0136].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Shick as modified by Thorne Jr. to include further comprising the medicinal agent, wherein the medicinal agent is contained in the storage part as taught by Thorne Jr., since such a modification would enable the syringe of Shick to delivery of medicinal agent in hypodermic injections. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 12, Shick as modified by Thorne Jr. disclosed all limitations of claim 1. Shick further disclosed wherein the medicinal agent storage device is attachable to and detachable from the catheter (Syringe 21 is removably connected to the filter and tubing 51 via luer lock 20 in Fig. 3).
Regarding claim 13, Shick as modified by Thorne Jr. disclosed all limitations of claim 1. Shick further disclosed wherein the filter (filter 10 in Fig. 3) is located at a position downstream of the medicinal agent storage device (inlet 12 is located under the syringe 21 and connected to syringe 21 via luer lock 20 in Fig. 3), and wherein the filter is configured to filter the medicinal agent (The distribution pathways 62 are configured to direct the fluid, filtered by the membrane 16, toward the central outlet port 52 and into the lumen 54 of the luer taper 50 [0042]).
Regarding claim 14, Shick as modified by Thorne Jr. disclosed all limitations of claim 13. Shick further disclosed wherein the first channel has a first inner diameter (luer taper 50 shown to have a diameter in Fig. 1), wherein the filter has a second diameter (disc shape of the syringe filter 10 in Fig. 1), and wherein the first inner diameter is smaller than the second diameter (luer taper 50 has a smaller diameter than the syringe filter 10 seen in Fig. 1).
Regarding claim 15, Shick as modified by Thorne Jr. disclosed all limitations of claim 13. Shick further disclosed wherein the filter is located between the first channel and the second channel (Syringe filter 10 is located between the luer lock 20 and luer taper 50 in Fig. 3).
Regarding claim 17, Shick as modified by Thorne Jr. disclosed all limitations of claim 1. Shick failed to explicitly disclose wherein the storage part has an injection port, and wherein the medicinal agent is configured to be injected to the storage part via the injection port.
However, Thorne Jr. teaches male fitting 60 (which is connected to the distal end of syringe 20 as seen in Fig. 16) is affixed to a source of drug to be transferred to syringe 20 [0135].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Shick as modified by Thorne Jr. to include wherein the storage part has an injection port, and wherein the medicinal agent is configured to be injected to the storage part via the injection port as taught by Thorne Jr., since such a modification would enable the syringe of Shick to be filled with ease prior to dispensing medicinal agent to the filter and catheter. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Response to Amendment
Applicant has set forth in their argument that the injection port is either located at the opening at the end of the outer sleeve (22) that receives the pusher (21) or at the opening at the end of the outer sleeve (22) that is nearest the conduit 23. Therefore, the Examiner accordingly withdraws the objection to the Drawings.
Applicant has amended claims 1 and 2 which were previously rejected under the U.S.C § 112(b) rejection. Examiner accordingly withdraws the 112(b) rejection of claims 1 and 2, and therefore the 112(b) rejections of claims 11-15 and 17 which were previously rejected due to their dependency on claim 1 is also withdrawn.
Response to Arguments
Applicant’s argument filed on 05/01/2026 have been fully considered but they are not found persuasive.
Applicant has argued that Shick and Thorne either separately or in combination fail to disclose wherein the flow control device includes a filter.
However, Examiner respectfully disagrees, as Shick discloses a flow control device (syringe filter 10 in Fig. 3).
The Applicant further made argument that Shick relies on a condition in which fluid flow is prevented due to a physical disconnection between components and not due to any characteristic of the filter itself. The Examiner respectfully disagrees. Shick teaches the interplay between the number, shape, and size of the distribution pathways 124, as well as the porosity of the membrane 106, determine the volume and pressure capacities of a particular syringe filter in Para [0057]. It can be interpreted that the membrane 106 and pathway 104 provides resistance against the flow in inlet port 28, and requires a specific pressure from the fluid to overcome this resistance.
The Applicant further made argument that Shick is directed to a syringe filter designed to facilitate and promote fluid flow through a membrane and not impede or prevent such flow. The Examiner respectfully disagrees due to the citations from Para [0057] and reasons set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Vincent et al. (US 4319996 A), related to a filter with membranes.
- Pestonik et al. (US 20070088252 A1), Apparatus with a valve.
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.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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