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 5 in reply filed on December 16th, 2025 is acknowledged. Applicant listed both “elected without traverse” and “elected with traverse” but clarified on phone that the election is made with traverse.
The traversal to the restriction between species groups is on the ground(s) that claims 1-2, 7-8, 11-15, 17 and 20 are generic to identified Species 1-4 “because the form of the medicinal agent (Species 1) and the configuration of the stopper (Species 2-4) are NOT mutually exclusive of the configuration of the filter in elected Species 5, such that features in those non-elected species could be present in combination with the elected features of the configuration of the filter in elected Species 5”. This is not found persuasive because the filter in Species 5 is not found to be present in combination with any of the configuration of stoppers in Species 2-4 or 6 in the Specification or Drawings. Applicant has further explicitly referred to the device of Fig. 1-3 as “first embodiment”, the device of Fig. 4 as “a modification of the first embodiment”, the device of Fig 5A-5C as “second embodiment”, the device of Fig 6A-6B as “third embodiment”, the device of Fig 7A-7B as “fourth embodiment” and the device of Fig 8 as being a “modification of the fourth embodiment”. By referring to each of these different devices as different “embodiments”, applicant has set forth that the different devices are species. As further evidence of this, each of the “stoppers” of Species 1-4 and each of the “filter members” of Species 5-6 are referred to as “flow control device” (Paragraph 14 for Species 1 and 2, Paragraph 30 for Species 3, Paragraph 37 for Species 4, Paragraph 44 for Species 5, and Paragraph 50 for Species 6) and the Specification does not disclose a single medical device that has more than one flow control device.
The requirement is still deemed proper and is therefore made FINAL.
Therefore claims 3-6, 9, 10, 16, 18 and 19 (as indicated by the Applicant) and claims 7, 8 and 20 (which read on non-elected Species 3 and 4) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawing Objections
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 injection port of claim 17 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 § 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.
Claim 1, 2, 11-15 and 17 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 1 requires the flow control device to be in “a first state” in line 10. Claim 13, which is dependent on claim 1 introduces a filter as the flow control device (filter member 70 in Specification [0044] and Drawing 7A-7B), however fails to point out in the Specification “a first state” configuration for the filter member, therefore making claim 1 indefinite. For the sake of Examination, “a first state” in claim 1 is being interpreted as the flow control device and catheter not being in a connection with medicinal agent storage device, which would prevent the medicinal agent from flowing from the storage part of the medicinal agent storage device into the first channel of the catheter. Applicant is therefore suggested to amend claim 1 to overcome rejection. Claims 2, 11-15 and 17 are also rejected due to their dependence on claim 1.
Claim 2, lines 1-2 recites “the flow control device is switchable between the first state and a second state” and therefore the “second state” suffers the same issue as in claim 1. For the sake of Examination, “a first state” in claim 1 is being interpreted as the flow control device and catheter not being in a connection with medicinal agent storage device, which would prevent the medicinal agent from flowing from the storage part of the medicinal agent storage device into the first channel of the catheter and “a second state” is being interpreted as the flow control device and catheter being in a connection with medicinal agent storage device, which would allow the medicinal agent to flow from the storage part of the medicinal agent storage device into the first channel of the catheter. Applicant is suggested to amend claim 2 to overcome rejection.
Claim 13 introduced “a filter” in line 1 and requires the filter to be in addition to the “flow control device” of claim 1. However, the Specification sets forth that the filter is the flow control device (Paragraph 44). Therefore, it is unclear how to interpret claim 13. For the sake of examination, claim 13 is being interpreted as reciting “wherein the flow control device comprises a filter”. Applicant is therefore suggested to amend claim 13 to overcome rejection. Claims 14 and 15 are also rejected due to their dependence on claim 13.
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 (Syringe 21 is removably connected to the filter 10 and tubing 51 by luer lock 20 in Fig. 3, therefore if syringe 21 is removed or disconnected from filter 10, then it can be interpreted as the filter 10 and catheter being in a first state to prevent flow from storage part of the syringe 21 to the first channel of the tubing 51), 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].
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 (Syringe 21 is removably connected to the filter 10 and tubing 51 by luer lock 20 in Fig. 3, therefore syringe 21 being removed from or connected to filter 10 can be interpreted as the filter 10 and catheter being in a first state or second state), and
wherein, in the second state, the flow control device is configured to allow the medicinal agent to flow from the storage part into the first channel (Syringe 21 is removably connected to the filter 10 and tubing 51 by luer lock 20, therefore if syringe 21 is connected to filter 10, then it can be interpreted as the filter 10 and catheter being in a second state to allow flow from storage part of the syringe 21 to the first channel of the 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 further comprising a filter (filter 10 in Fig. 3) 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), 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783