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 .
This action is in response to Applicant’s amendment file on January 26, 2026
Claims 1-7, 14, and 18-20 are being examined.
Claims 8-13 and 15-17 are withdrawn.
Election/Restrictions
Claims 8-13 and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 26, 2026. Claims 1-7, 14, and 18-20 are being examined.
Applicant's election with traverse of Species I in the reply filed on Janu is acknowledged. The traversal is on the ground(s) that “Applicant respectfully traverses the species restriction on the basis that there would be no serious search and/or examination burden. As set forth in the Manual of Patent Examining Procedure (MPEP) § 803, there are two criteria for a proper requirement for restriction between patentably distinct inventions: (A) the inventions must be independent or distinct as claimed; and (B) there would be a serious burden on the Examiner if restriction is not required. Applicant respectfully submits that at least criterion (B) is not met in this application, and that any burden on the Examiner in addressing Species I-V in this application is minimal. Each species does have features exclusive to that species; however, each species is directed to an occlusion device configured to stop flow through a fluid conduit coupled to a side port of an IV catheter assembly. Therefore, a search query for any one of the Species I-V would likely include similar or identical search terminology and when searching and examining one of the Species I-V, the Examiner will also encounter subject matter of the other species. Accordingly, Applicant respectfully submits that a serious search burden does not exist for searching and examining Species I-V in a single application." . This is not found persuasive because a serious search burden on the examiner exists because each species has unique and mutually exclusive characteristics that would require a different field of search. The embodiments include an occlusion device with a clamp, a button, a latching mechanism, a slide clamp, and a valve. The mechanics of each of these .
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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 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, 5, 14, 18-20 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Abitabilo et al. (US 2017/0239443 A1, herein Abitabilo).
Regarding claim 1, Abitabilo discloses an intravascular assembly (intravenous catheter assembly 100, Fig. 2A), comprising:
a catheter adapter (catheter hub 110, Fig. 10A) comprising:
a distal end (distal end 136, Fig. 10B)
a proximal end (proximal end 138, Fig. 10B);
a lumen arranged between and in fluid communication with the distal end and the proximal end (internal fluid passage 142, Fig. 10B)
a catheter (catheter tube 108, Fig. 2B) arranged at the distal end of the catheter adapter (Fig. 10B) and in fluid communication with the lumen (“… the catheter tube 10B is in fluid communication with the first internal fluid passageway 142, Fig. 10B); and
a side port (side port 150, Fig. 10B) in fluid communication with the lumen (“The side port 140 is in fluid communication with the first internal fluid passageway 142.’ – Para [0129]);
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a fluid conduit (extension tube 114, Fig. 28) having a distal end (See annotated Fig. 28) and a proximal end (See annotated Fig. 28), the distal end of the fluid conduit coupled to the side port (“Side port 150 can provide a connection point to one or more lengths of extension tube 114.” – Para [0129], Fig. 28);
a connector (coupling 115, Fig. 28) arranged at the proximal end of the fluid conduit (“… coupling 115 is fixedly coupled to the extension tube 114 at one end…” – Para [01167]); and
an occlusion device (extension tube clamp 116, Fig. 28) configured to stop flow through the fluid conduit (“… clamp 116 can be constructed of a resilient material that can be deformed to selectively occlude the extension tube 114 to restrict the passage of fluid.” – Para [0160]).
Regarding claim 5, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
the clamp is formed of an elastomeric material (“… the extension tube 116 can be constructed of a resilient material that can be deformed …” – Para [0160]).
Regarding claim 14, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
the occlusion device (extension tube clamp 116, Fig. 28) is arranged between the side port (side port 150, Fig. 10B) and the connector (coupling 115, Fig. 28)
Regarding claim 18, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
the connector (coupling 115, Fig. 28) is a t-connector or a y-connector (“… “Y” coupling 115.” – Para [0167])
Regarding claim 19, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, further comprising
a needleless access connector (needleless connectors 118, Fig. 28) coupled to the connector (“Needleless connectors 118A/B can be operably coupled to extension tube 114 by a “Y” coupling 115.” – Para [0167])
Regarding claim 20, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
the needleless access connector (needleless connectors 118, Fig. 28) is releasably coupled to the connector (“… coupling 115 includes one or more portions of a luer lock connection at the other ends for respective coupling to needleless connectors 118A/B.” – Para [0167])
Examiner interprets a luer lock connection as a type of releasable couple.
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abitabilo et al. (US 2017/0239443 A1, herein Abitabilo) in view Thornley (US2021/0379336 A1).
Regarding claim 2, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, further comprising
Abitabilo does not expressly disclose a dressing having a bottom surface configured to contact a patient’s skin.
Thornley teaches a dressing (dressing 800, Fig. 8) having a bottom surface configured to contact a patient’s skin (“… dressing 800 may include an adhesive underside that adheres to the patient’s arm.” – Para [056]) and a top surface (Fig. 8).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the intravascular assembly of Abitabilo to include disclose a dressing having a bottom surface configured to contact a patient’s skin as taught by Thornley so that the catheter assembly may be secured to the patient's arm by the placement of the dressing (Thornley, Para [0056]).
Regarding claim 3, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
Abitabilo does not expressly disclose that the occlusion device is coupled to the top surface of the dressing
Thornley teaches that the occlusion device (slideable collar 316, Fig. 8) is coupled to the top surface of the dressing (“The slideable collar 316 is shown to be operably disposed on… the dressing 800.” – Para [0006], Fig. 8)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, modify the intravascular assembly of Abitabilo to include that the occlusion device is coupled to the top surface of the dressing as taught by Thornley so that the catheter assembly may be secured to the patient's arm by the placement of the dressing (Thornley, Para [0056]).
Claim(s) 4, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abitabilo et al. (US 2017/0239443 A1, herein Abitabilo) in view of Schaffer (US Patent No. 5429616).
Regarding claim 4, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
the occlusion device is a clamp (extension tube clamp, Fig. 2A)
Abitabilo does not expressly disclose comprising a base and first and second arms extending substantially perpendicularly from the base, the base and the first and second arms defining a channel configured to receive the fluid conduit
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Schaffer teaches comprising a base (See annotated Fig 4) and first (locking member 44, Fig. 4) and second arms (locking member 46, Fig. 4) extending substantially perpendicularly from the base (“Two spaced apart locking member 44 and 46 protrude substantially tangentially from hub tubular side wall portion 28 …” – Para [6]), the base and the first and second arms defining a channel (See annotated Fig. 4) configured to receive the fluid conduit (side wall 28, Fig. 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the intravascular assembly of Abitabilo to include comprising a base and first and second arms extending substantially perpendicularly from the base, the base and the first and second arms defining a channel configured to receive the fluid conduit as taught by Schaffer to collapse side wall 28 (Schaffer, Para [6]).
Regarding claim 6, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
Abitabilo does not expressly disclose that the first arm and the second arm are resiliently biased toward the channel
Schaffer teaches that the first arm (locking member 44, Fig. 4) and the second arm (locking member 46, Fig. 4) are resiliently biased toward the channel (“… holding member 44 and 46 toward each other in the compression mode …” – Para [7], Fig. 4)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the intravascular assembly of Abitabilo to include that the first arm and the second arm are resiliently biased toward the channel as taught by Schaffer to collapse sidewall 28 (Schaffer, Para [6])
Regarding claim 7, Abitabilo discloses the intravascular assembly (intravenous catheter assembly 100, Fig. 2A), recited above, wherein
Abitabilo does not expressly disclose that a diameter of the channel is less than a diameter of the fluid conduit, such that when the fluid conduit is received by the channel, fluid flow through the fluid conduit is slowed and/or stopped
Schaffer teaches that a diameter of the channel is less than a diameter of the fluid conduit (side wall 28, Fig.4) (See annotated Figs. 3 and 4), such that when the fluid conduit is received by the channel (“… transmit the compressive force from locking members 44 and 46 to side wall 28.” – Para [6]), fluid flow through the fluid conduit is slowed and/or stopped (“This closure prevents blood from escaping …” – Para [9]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to include that a diameter of the channel is less than a diameter of the fluid conduit, such that when the fluid conduit is received by the channel, fluid flow through the fluid conduit is slowed and/or stopped as taught by Schaffer to collapse side wall 28 (Schaffer, Para [6]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783