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 without traverse of Species A (Fig. 2A-2E; Clm. 1-11 and 15) in the reply filed on 09 March 2026 is acknowledged, Claims 12-14 and 16-20 is/are withdrawn as being directed toward a non-elected species/invention.
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) 11 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,240,960 (“Fillmore”).
Regarding Claim 11, Fillmore discloses a catheter system, comprising:
a catheter adapter (100) comprising a distal end (24, 16), a proximal end (24, 18), a lumen (110) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (see Fig. 4), and a side port (120) disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter;
a catheter (not shown) extending from the distal end of the catheter adapter (Col. 4, Ln. 29-33; Col. 8, Ln. 43-55 – re: Fillmore envisages connecting either end 16 or 18 to either a catheter, drainage bag, or tubing such that a configuration wherein end 16 is connected to a catheter so as to define a “distal end” in accordance with the claims is immediately envisaged by the disclosure of Fillmore);
an annular valve (108) disposed within the lumen and configured to seal the side port (Col. 9); and
an instrument advancement feature (128), wherein when an instrument is inserted through the side port, the instrument advancement feature is configured to direct the instrument in a distal direction within the lumen of the catheter adapter (see generally Fig. 5 – i.e. when an instrument is inserted through the lumen 46 of the instrument advancement feature the angled distal end will redirect the instrument toward the distal end 16 – whereby express discussion by Fillmore of such an instrument is not required to satisfy the metes and bounds of the instant claims).
Regarding Claim 15, Fillmore discloses a needleless access connector, comprising:
a first end (30) comprising a female luer; and
a second end (126, 128, 131) coupled to the side port, wherein the second end comprises the instrument advancement feature (see Fig. 4), wherein the instrument advancement feature comprises a curved portion (44, 48), wherein the curved portion comprises a trough or an enclosed pathway (see Fig. 5).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0120034 (“Kaczorowski”) in view of Applicant’s Admitted Prior Art (“AAPA”).
Regarding Claim 1, Kaczorowski discloses an instrument delivery device to insert an instrument through a catheter assembly, the instrument delivery device comprising:
An instrument (60) and a connector (30), wherein the instrument is configured to advance beyond the connector (see Fig. 3A), wherein the connector comprises a curved portion (33a) configured to change a direction of the instrument when the instrument is advanced through the connector (see Fig. 3A).
Kaczorowski discloses the invention substantially as claimed except that instrument is disposed within a housing coupled to the connector at its distal end as claimed. Rather, Kaczorowski merely recites that the instrument (60) may comprise a suitable “intervention device” selected from “any diagnostic and therapeutic device used in medical procedures” (Par. 50) without any additional exposition concerning the specific structure of the intervention device. However, APAA (see Fig. 1A – Par. 63) describes a suitable intervention device used in association with catheters comprising:
A housing (12), comprising a proximal end (14), a distal end (16), and a slot (18) disposed therebetween;
The housing having a connector (20) at its distal end configured to be attached to a corresponding connector
A slider (22) configured to move along the slot (Par. 64); and
An instrument (11) disposed within the housing and coupled to the slider, wherein the instrument is configured to advance beyond the connection interface and catheter connector and into a catheter in response to movement of the slider along the slot from a proximal position to a distal position (Par. 64). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the connector of Kaczorowski to have a suitable connection geometry and membrane to permit receipt of the intervention device of AAPA in order to allow the two devices to be paired together such that the blood draw instrument of AAPA can be used in an expected and predictable manner to permit an interventional procedure such as a blood draw as is known in the art.
Regarding Claim 2, Kaczorowski discloses the curved portion is configured to change a direction of the instrument when the instrument is advanced through the connector (see Fig. 3A – Par. 49).
Regarding Claim 3, Kaczorowski discloses the curved portion comprises a trough (see Fig. 3A, 5A, 5B) – re: “a conduit, drain, or channel [for water]” – see Merriam-Webster’s Online Dictionary.
Regarding Claim 4, Kaczorowski discloses the curved portion comprises an enclosed pathway (see Fig. 3A, 5A, 5B).
Regarding Claim 5, Kaczorowski discloses the enclosed pathway is disposed within a straight end of the connector (see e.g. Fig. 5B).
Regarding Claim 6, Kaczorowski discloses the connector comprises a male luer (Par. 54) configured to form a seal within the catheter assembly, wherein the straight end extends from the male luer (see Fig. 5B).
Regarding Claim 7, Kaczorowski discloses the enclosed pathway is disposed within a curved end of the connector (see Fig. 3A).
Regarding Claim 8, Kaczorowski discloses the connector comprises a male luer (Par. 54) configured to form a seal within the catheter assembly, wherein the curved end extends from the male luer (see e.g. Fig. 3A).
Regarding Claim 9, Kaczorowski discloses a side arm (37) which is diametrically opposed to the curved portion (see Fig. 3A) such that, in use, it can be used as a directional indicator to indicate to a clinician an orientation of the instrument delivery device with respect to the catheter assembly such that the curved portion is configured to direct the instrument in a distal direction within the catheter assembly (i.e. the user, knowing that the side arm and curved portion are diametrically opposed will be able to position the curved portion in a desired position by positioning the side arm in the opposing direction as shown).
Regarding Claim 10, AAPA discloses the connector (20) – wherein in light of Applicant’s elected embodiment it should be understood that the “connector” comprises a two part construction (see Fig. 2B) - comprises an insertion portion and a plurality of arms, wherein the insertion portion is configured to insert into the catheter assembly, wherein the plurality of arms are configured to snap onto an exterior of the catheter assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
05/04/2026
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