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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/28/2023 and 01/25/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election with traverse of invention (I) and species (1) drawn to claims 1-6 and 10-12. Claims 7-9 and 13-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/05/2025.
Response to Arguments
Applicant's arguments filed 11/05/2025 regarding there won’t be search and/or examination burden to examine all inventions and species have been fully considered but they are not persuasive, because the different inventions and distinct species are directed to various embodiment having different structural elements that requires different modes of operation, that will cause serious search and/or examination burden.
Claim Objections
Claim 5 is objected to because of the following informalities: the phrase “the distal end” in line 2 should be amended to read –the distal end of the introducer--. Appropriate correction is required.
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.
Claim(s) 1, 2, 4-6, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehrenreich et al (US 2018/0272107).
As to claim 1, Ehrenreich teaches a medical device (medical device 100, 200 and/or 900, fig.1-4 and 42-43), comprising:
a catheter (catheter 160, 260 and/or 960, fig.1-4, 42-43) having a proximal end (proximal end portion 161 of catheter 160, par.62, fig.1 and/or proximal ends of catheters 260/960, fig.3-4 and 42-43), a distal end (distal end portion 162 of catheter 160, fig.1, and/or distal ends of catheters 260/960, fig.3-4 and 42-43), and a sidewall therebetween defining a lumen (lumen 163 of catheter 160, fig.1, lumens of catheters 260/960, fig.3-4 and 42-43) therethrough;
an introducer (introducer 110, 210 and/or 910, par.162, fig.1-4 and 42-43) having a proximal end (proximal end 111, fig.1 and/or proximal ends of introducers 210/910, fig.1-4 and 42-43), a distal end (distal end 112 of introducer 110, and/or distal ends of introducers 210/910, fig.1-4 and 42-43), and a sidewall therebetween defining an inner volume (inner volume 113 of introducer 110, inner volume 213 of introducer 210, and/or inner volume 913 of introducer 910, fig.1-4 and 42-43) configured to movably receive the catheter (par.66-67, par.88 and par.162, fig.1-4, 42-43), the distal end of the introducer having a lock (lock of introducer 110, par.62-64, lock 240, and/or lock 940, fig.1-4, 42-43) configured to couple the introducer to an intravenous line (lock couples introducer 110 to intravenous line 105, and/or locks 240/940 couples introducers 210/910 to intravenous line, par.60-64 and par.68, fig.2, fig.3-4, 42 and 43),
the introducer further having a flexible member (internal support member in introducer 110 or 210, and/or internal support member 986, par.67, par.161-163, fig.1-4 and 42-43) arranged within the inner volume configured to limit deflection of the catheter as the catheter is moved within the introducer (the internal support member 986 can support the catheter 960 to limit and/or substantially prevent undesired deflection and/or deformation of the catheter 960, par.163); and
an actuator (actuator 170, 270 and/or 970, fig.1-4 and 42-43) movably coupled to the introducer (par.68, par.81 and par.162), the actuator having a first portion (first portion 971 outside introducer 910, par.162, fig.42-43) disposed outside of the introducer and a second portion (second portion 975 inside introducer 910, par.162, fig.42-43) disposed in the inner volume of the introducer and coupled to the catheter (second portion 975 of the actuator 970 is disposed within the inner volume 913 of the introducer 910 and is fixedly coupled to a distal end portion of the catheter 960, par.162),
the actuator configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer (position of catheter shown in fig,1 and/or 42, the actuator 970 to move the catheter 960 between a first position (e.g., a proximal position), in which the catheter 960 is disposed within the introducer 910 and/or the lock 940, par.162), and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer such that at least a first portion of the catheter is disposed within the intravenous line when the introducer is coupled to the intravenous line (position shown in fig.2, a second position (e.g., a distal position), in which at least a portion of the catheter 960 extends distally beyond the lock 940, as described in detail above with reference to the transfer device 200, par.162).
As to claim 2, Ehrenreich teaches the medical device, wherein the flexible member is arranged along a longitudinal axis within the inner volume of the introducer (the internal support member 986 is a substantially cylindrical tube having a diameter that allows the internal support member 986 to be disposed within the inner volume 913, par.163, fig.42-43).
As to claim 4, Ehrenreich teaches the medical device, wherein the flexible member and the introducer define a substantially cylindrical passage within which the catheter is received (internal support member 986 is shown and described above as being a substantially cylindrical tube in which the catheter 960 is disposed, par.163 and par.165, fig.42-43).
As to claim 5, Ehrenreich teaches the medical device, wherein the flexible member extends from the proximal end of the introducer to the distal end (internal support member 986 is shown and described above as being a substantially cylindrical tube in which the catheter 960 is disposed, as best seen in fig.42-43, internal support member 986 extends from distal to proximal end of introducer 910, par.161-165, par.42-43).
As to claim 6, Ehrenreich teaches the medical device, wherein the flexible member is a unitary member (the internal support member 986 is a substantially cylindrical tube disposed within the inner volume 913, as best seen in fig.42-43 support member 986 is a unitary member).
As to claim 10, Ehrenreich teaches the medical device, wherein, as the actuator is moved toward the distal end of the introducer, the second portion of the actuator displaces the flexible member (second portion 975 of the actuator 970 can be disposed within the internal support member 986, this arrangement of the actuator 970 and the internal support member 986 is such that when a user moves the actuator 970 along a length of the introducer 910, the second portion 975 of the actuator 970 and the catheter 960 are moved within the internal support member 986, the movement of the actuator 970 along the introducer 910 results in a rotation of the internal support member 986, par.164, fig.42-43).
As to claim 11, Ehrenreich teaches the medical device, wherein the second portion of the actuator is coupled to the proximal end of the catheter (as best seen in fig.3-4 and/or 42-43, actuator 270/970 are coupled to proximal end of catheter 260/960, par.93 and par.162).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being obvious over Ehrenreich et al (US 2018/0272107).
Ehrenreich teaches the invention substantially as claimed above, but failed to explicitly teach the flexible member comprises an elastomeric material. However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to form internal support member taught by Ehrenreich’s invention from elastomeric material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being obvious over Ehrenreich et al (US 2018/0272107), in view of Lim et al (US 2017/0296112).
As to claim 12, Ehrenreich teaches the device can be used to withdraw bodily fluids and/or infusing drugs (par.60), but failed to explicitly teach a lubricant received within the inner volume. However, Lim teaches a device for withdraw bodily fluids and/or infusing drugs (abstract, and par.9-15) in the same field of endeavor, wherein inner volume of the device comprises lubricant (tubing or other portions of the system can be coated (e.g., with a lubricant) to facilitate flushing, end of par.346, sample chamber comprises lubricant, claim 33).
Since inner volume lubricants are well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include lubricant in the inner volume of the introducer taught by Ehrenreich’s invention, as sample chamber lubricant taught by Lim’s invention, to facilitate flushing and removal of the sample of bodily fluid from the sample chamber, as taught by Lim’s invention (par.346 and claim 33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791