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 .
Response to Amendment
The amendment filed 6/18/2026 has been entered. Claims 1-5, 13, and 21-25 are pending in the application. Applicant’s amendments to the Drawings and Claims have not overcome each and every objection previously set forth in the Non-Final Office Action mailed 3/18/2026.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities: “extending through the cylindrical surface from a distal end of the cylindrical surface to a proximal end of the cylindrical surface” should be corrected to “extending through the cylindrical surface from the distal end of the cylindrical surface to the proximal end of the cylindrical surface” for claim language consistency. Appropriate correction is required.
Applicant is advised that should claims 21-22 or 24-25 be found allowable, claims 1-2 or 4-5 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).
Drawings
The drawings are objected to because reference numeral 22 in Fig. 1C is incorrectly used to designate 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 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, 13, and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loveless (US 4269186 A) in view of Luther (US 5743882 A), and further evidenced by Stout (US 20120016301 A1).
Regarding claims 1 and 21, 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 flashback chamber 21 in 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, 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); and a needle hub comprising the flash chamber and surrounding the neck portion (chamber 16 configured to hold needle 12 through interface 37, col 2 line 48-col 3 line 23 & Fig. 2; chamber 16 comprises flashback chamber 21 and surrounds male projection 36, col 2 lines 48-col 3 line 8 & Fig. 2).
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 to the distal end of the body, wherein an outer edge of each of the plurality of disc-shaped portions comprises a cylindrical surface having a distal end and a proximal end, wherein the outer edge of each of the plurality of disc-shaped portions further comprises an air vent channel extending through the cylindrical surface from a distal end of the cylindrical surface to a proximal end of the cylindrical surface, wherein the air vent channel of the proximal-most disc-shaped portion is aligned with the vent hole.
Luther teaches a similar configuration to Loveless, in which a tapered cylindrical inner boss 54 extends from the inside of apparatus 52 (Fig. 4-5 of Luther), similar to projection 36 extending from the inside of body 28 (Fig. 1-5 of Loveless). Luther discloses that “apparatus 52 may comprise a cap like structure having a tapered cylindrical inner boss 54 located between two (2) forwardly extending outer struts 56… A gripping surface 60 such as a series of longitudinal grooves or corrugations is preferably formed about the outer surface of the locator apparatus 52 to facilitate grasping and turning of the blunting apparatus 16 during use...” (col 4 lines 17-28 of Luther).
Luther teaches a plug for use in plugging a proximal end of a flashback chamber in an intravenous catheter assembly (a proximal engagement member 52a for use in plugging a proximal end of hollow flash chamber bore 38 in an intravenous catheter C assembly, abstract and Col 4 line 65-col 5 line 21 and col 6 lines 10-22 & Fig. 7-8b), 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 52a positioned distally to proximal surface 62, which is being interpreted as a neck portion, comprising engagement fins 60, which are circular and being interpreted as the disc-shaped portions, col 4 line 65-col 5 line 21 & Fig. 7-8B; the spaces between engagement fins 60 are being interpreted as annular grooves, see Fig. 7-8b), wherein an outer edge of each of the plurality of disc-shaped portions comprises a cylindrical surface having a distal end and a proximal end (the outer edge of each fin 60 comprises a cylindrical surface, as each fin 60 is disc-shaped, with each cylindrical surface having a distal end and a proximal end, see Fig. 7-8b).
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 Luther to include a plurality of annular grooves spaced apart by a plurality of disc-shaped portions, wherein an outer edge of each of the plurality of disc-shaped portions comprises a cylindrical surface having a distal end and a proximal end, 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 12 lines 17-59 and col 5 lines 35-57 & Fig. 7-8b of Luther).
As modified, engagement fins 60 of Luther would be included on projection 36 of Loveless. Fins 60 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 Luther.
As combined, the proximal-most fin 60 would be disposed proximate forward edge 32 of body 28 (see Fig. 2 of Loveless), as fins 60 would run the length of projection 36, and the outer edge of each of fins 60 would comprise openings at their intersections with air passageways 52, the openings extending completely through the cylindrical outer surface from a distal end to a proximal end. Part of passageway(s) 52 intersecting the proximal-most fin 60 would remain aligned with opening(s) 54. Each part of passageways 52 passing through a corresponding fin 60 may be interpreted as the air vent channel.
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 60 of Luther, 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 claims 2 and 22, Loveless, as modified, discloses all the limitations of claims 1 and 21. 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 60 provided on projection 36 may be interpreted as forming a distal end of projection 36, Fig. 2-3 of Loveless and Fig. 7-8b of Luther).
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 60 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 60, creating a step, see Fig. 2-3 of Loveless and Fig. 7-8b of Luther).
Regarding claims 4 and 24, Loveless, as modified, discloses all the limitations of claims 1 and 21. 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 claims 5 and 25, Loveless, as modified, discloses all the limitations of claims 1 and 21. 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).
Regarding claim 23, Loveless, as modified, discloses all the limitations of claim 21. Loveless further discloses the catheter assembly of claim 21, wherein the proximal-most disc-shaped portion and the distal end of the body form a stepped surface (as modified, the proximal-most fin 60 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 60, creating a step, see Fig. 2-3 of Loveless and Fig. 7-8b of Luther) contacting a proximal end of the needle hub (the stepped surface, formed by edge 32 and a proximal-most fin 60, contacts a trailing, proximal end of chamber 16, col 3 lines 24-31 & Fig. 2; chamber 16 configured to hold needle 12 through interface 37, col 2 line 48-col 3 line 23 & Fig. 2).
Response to Arguments
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the fins do not appear to include a cylindrical surface having a distal and proximal end, the Examiner finds that fins 60 are disc shaped and three dimensional. The outer edge of fins 60 include a cylindrical surface and the fins 60 have a thickness, the thickness defined by a proximal and distal end.
In response to Applicant’s arguments that the fins do not appear to include an air vent channel, the Examiner finds that, as modified, fins 60 include air vent channels at their intersections with passageways 52.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Suzuki (US-4682980-A) and Cole (US-5312345-A).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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