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, claims 1-5, 10, and 13, in the reply filed on January 23rd 2026 is acknowledged.
Claims 6-9, 11-12, and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 23rd 2026.
Drawings
The drawings are objected to because reference numeral 22 in Fig. 1C has been used twice. One of reference numerals 22 is incorrectly used to designate, what the Examiner believes to be, the proximal end of the needle hub, which should be reference numeral 24. 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 Objections
Applicant is advised that should claim 4 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1-5, 10, and 13 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.
Regarding claim 1, the limitation of “wherein a proximal-most disc-shaped portion of the plurality of disc-shaped portions is disposed proximate the body” renders the claim unclear. Based on the specification and drawings, it appears the proximal-most disc-shaped portion is disposed proximate to the distal end of the body 38, not the body, as no disc-shaped portion is disposed proximate to proximal end 62 of body 38. For purposes of examination, claim 1 will be interpreted as limiting the proximal-most disc-shaped portion to be disposed proximate the distal end of the body.
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) 1-5, 10, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loveless (US 4269186 A) in view of Overton (US 6106499 A), and further evidenced by Stout (US 20120016301 A1).
Regarding claim 1, Loveless discloses a plug for use in plugging a proximal end of a flashback chamber in an intravenous catheter assembly (air bleed plug 20 for use in plugging a proximal, trailing end of blood detection chamber 16 in intravenous catheter placement assembly 10, Col 2 lines 50-55 and Col 3 lines 24-34 & Fig. 1-5), the plug providing air venting of the flashback chamber (“Under pressure of said cardiovascular system, air contained within the hollow interior of the blood detection chamber 16 is caused to pass between the ribs 50, along the passageways 52 and to the atmosphere through the openings 54 in the flange 34 of the plug 20.”, Col 4 lines 20-25 & Fig 1-5), the plug comprising: a body, comprising a cavity and a vent hole extending distally from the cavity (cylindrical body 28, including annular radially-directed bleeder shoulder or flange 34, comprising an interior 41 and openings 54 extending distally from interior 41, through flange 34, Col 3 line 35-Col 4 line 1 & Fig. 1-5);
a neck portion extending from a distal end of the body (forwardly directed male projection 36 extending distally from a distal end of flange 34 of body 28, Fig. 1-5; the distal end of body 28 is being interpreted as the distalmost surface of body 28 and flange 34, which can be defined as edge 32 and the distal surface of flange 34, see Fig. 2-3 and 5 & Col 3 lines 36-45), wherein an outer edge of the neck portion comprises an air vent channel generally aligned with a longitudinal axis of the plug, wherein the air vent channel is aligned with the vent hole (the outer edge of projection 36 comprises air passageway 52 defined by longitudinally-directed ribs 50, with “opening 54… in alignment with each passageway 52.” Col 3 lines 54-61 & Fig. 1-5).
Loveless further teaches that “Once blood is visibly confirmed by the user as being present in light transmitting chamber 16, the needle 12 together with blood detection chamber 16 and plug 20 are removed from the catheter tube assembly and discarded.” (Col 4 lines 25-32).
However, Loveless fails to explicitly disclose wherein the neck portion comprises a plurality of annular grooves spaced apart by a plurality of disc-shaped portions, wherein a proximal-most disc-shaped portion of the plurality of disc-shaped portions is disposed proximate the body, wherein an outer edge of each of the plurality of disc-shaped portions comprises an air vent channel generally aligned with a longitudinal axis of the plug, wherein the air vent channel of the proximal-most disc-shaped portion is aligned with the vent hole.
However, Overton teaches a plug for use in plugging a proximal end of a flashback chamber in an intravenous catheter assembly (unidirectional positioning member 44 for use in plugging a proximal end of flash chamber 32 in intravenous cannula assembly 10, Col 3 fourth paragraph & Fig. 1-5), comprising a neck portion, wherein the neck portion comprises a plurality of annular grooves spaced apart by a plurality of disc-shaped portions (the portion of member 44 positioned distally to proximal surface 50, which is being interpreted as a neck portion, comprising engagement fins 46, which are circular and being interpreted as disc-shaped portions, Col 3 second paragraph & Fig. 1-5; the spaces between engagement fins 46 are being interpreted as annular grooves, see Fig. 2 and 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plug of Loveless with Overton to include a plurality of annular grooves spaced apart by a plurality of disc-shaped portions since such a modification would provide structure to ensure the flashback chamber and plug are tightly secured together upon removal from the remainder of the catheter assembly and prevent inadvertent proximal retraction of the plug and yield predictable results pertaining to plug connection with a flashback chamber (Col 1 line 62-Col 1 line 7, Col 3 lines 40-56, and Col 4 lines 10-23 & Fig. 6a-6c of Overton).
As modified, engagement fins 46 of Overton would be included on projection 36 of Loveless. Fins 46 would be disposed around air passageways 52, leaving air passageways 52 unobstructed to allow for their continued, intended use, as would be apparent to one of ordinary skill in the art, while providing frictional engagement with the inner wall of the flashback chamber, as taught by Overton.
As combined, the proximal-most fin 46 would be disposed proximate forward edge 32 of body 28 (see Fig. 2 of Loveless) and the outer edge of each of fins 46 would comprise openings corresponding to air passageways 52. Such a combination is known in the art as further evidenced by Stout. Stout teaches a similar configuration wherein septum 50 and septum activator 80 are configured to act as a plug for a catheter adapter 14 separating lumen 36 of adapter 14 into multiple chambers, 62 and 116 (flashback chambers) and 64 ([0029], [0031], and [0034]-[0035] & Fig. 3-4 of Stout). Septum activator 80 includes a ring-like seal 98, similar to one of fins 46 of Overton, which prevents blood flowing out of the proximal end of adapter 14, including one or more air vents 100 ([0038]-[0039] and [0042] & Fig. 4-5 and 7 of Stout). Air vents 100 are longitudinally aligned channels disposed on an outer edge of ring-shaped seal 98 to allow air to escape to the exterior environment ([0042] & Fig. 7 of Stout).
Regarding claim 2, Loveless, as modified, discloses all the limitations of claim 1. Loveless further discloses the plug wherein a distal-most disc-shaped portion of the plurality of disc-shaped portions forms a distal end of the neck portion (as modified, the distal-most fin 46 provided on projection 36 may be interpreted as forming a distal end of projection 36, Fig. 2-3 of Loveless and Fig. 2 and 4-5 of Overton).
Regarding claim 3, Loveless, as modified, discloses all the limitations of claim 1. Loveless further discloses the plug wherein the proximal-most disc-shaped portion and the distal end of the body form a stepped surface (as modified, the proximal-most fin 46 and forward edge 32 of body 28 can be interpreted as forming a stepped surface as edge 32 is disposed outwardly and proximally to the proximal-most fin 46, creating a step, see Fig. 2-3 of Loveless and Fig. 2 and 4-5 of Overton).
Regarding claims 4 and 10, Loveless, as modified, discloses all the limitations of claim 1. Loveless further discloses the plug wherein a proximal end of the body comprises an opening of the cavity (a proximal end of body 28 comprises an opening of interior 41, Fig. 2).
Regarding claim 5, Loveless, as modified, discloses all the limitations of claim 1. Loveless further discloses the plug wherein a surface of the cavity comprises a plurality of annular protrusions (“The interior 41 of the cylindrical body 28 of air bleed plug 20 may be lined at various axial locations with one or more small strengthening radial ribs 42.”, Col 3 lines 35-37 & Fig. 2).
Regarding claim 13, Loveless, as modified, discloses all the limitations of claim 1. Loveless further discloses the plug wherein a proximal end of the neck portion and the distal end of the body form a stepped surface (the proximal end of projection 36 and the distal surface of flange 34 form a stepped surface, see Fig. 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Engelman (US-4444203-A), Ingram (US-20180280681-A1), Burkholz (US-20170120011-A1), and Chiarin (US-20150257694-A1). McFarlane teaches a plug (flashback structure 10, Fig. 1) for use in an intravenous catheter assembly (abstract & Fig. 1), the plug providing air venting (“A vent means is formed in direct fluid communication with the flow channel so that air being forced from the flow channel as blood enters therein can readily pass from the base to the exterior thereof.”, Col 2 lines 52-55), the plug comprising: a body (nose portion 24, Fig. 1 and 5); a neck portion extending from the body (base 12, Fig. 1 and 5), wherein the neck portion comprises an air vent channel generally aligned with a longitudinal axis of the plug (base 12 comprises two elongated vent channels 50 and vent port 52, see Col 5 lines 1-20 & Fig. 3 and 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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.
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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783