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 7/24/2026 has been entered. Claims 1 and 3-18 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 4/30/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 3-15 of copending Application No. 17898617 in view of Blanchard (US 20200078564 A1). Claim 1 of 17898617 teaches all the limitations of claim 1 of the instant application except for "…a blood draw device comprising a flow tube configured to be extended through the needle- free connector, through the intermediate tubing, through the inlet of the catheter adapter, and through the catheter".
However, Blanchard teaches a blood draw device comprising a flow tube (instrument 80 comprising an additional catheter for blood draw, [0006], [0041], and [0057]-[0061] & Fig. 2A-2B and 3A-3B) configured to be extended through the needle-free connector, through the intermediate tubing, through the inlet of the catheter adapter, and through the catheter (“the first connector 48 and/or the second port 52 may be disposed in proximity to the catheter adapter 32 and the catheter 40 to improve access for an instrument… the instrument may include an additional catheter for fluid infusion or blood draw… a length of the first extension tube 42 may be about 12 millimeters… The length of the first extension tube 42 may vary, according to some embodiments.”, [0041] & Fig. 2A-2B; instrument 80 configured to be extended through connector 48, through tube 42 into catheter adapter 32, through side port 38, and necessarily through catheter 40 to facilitate blood withdrawal, [0057]-[0061]; “The present disclosure relates generally to devices, systems, and methods for facilitating delivery of an instrument and/or fluid through a catheter, which may include a peripheral intravenous catheter (PIVC).”, [0006).
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 device as claimed with Blanchard to include a blood draw device comprising a flow tube configured to be extended through the needle-free connector, through the intermediate tubing, through the inlet of the catheter adapter, and through the catheter, since such a modification would provide means for withdrawing blood from a patient for sampling or testing ([0006] and [0041] of Blanchard).
Claims 3-15 of application 17898617 teach all the limitations of claims 3-15 of the instant application. This is a provisional nonstatutory double patenting rejection.
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, 3-8, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1), in view of Bihlmaier (US 20190091462 A1).
Regarding claim 1, Blanchard discloses a system (catheter assembly 30 and instrument 80, [0040]-[0041] and [0057]-[0061] & Fig. 2A-3B) comprising: an integrated intravenous catheter (catheter assembly 30, [0040] & Fig. 2A-2B) comprising: a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature (catheter adapter 32 comprising catheter 40 and side port 38, abstract and [0040] & Fig. 2A-2B);
a needle-free connector comprising a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port (first connector 48 including a third port 64, which is being interpreted as the first port, a second port 52, and a first port 50, which is being interpreted as the side port, [0046]-[0047] & Fig. 2A-2B and 6A), the second port comprising a valve member (“one or more of the first port 50, the second port 52, and the third port 64 may be coupled to a needleless connector, such as, for example, the Becton Dickinson SMARTSITE™ needle-free valve, or another suitable needleless connector”, [0049] & Fig. 2A-2B),
wherein the needle-free connector comprises a body defining a first flow path extending between the first port and the second port (connector 48 comprises a body defining a fluid pathway between port 64 and port 52 for fluid injections, see [0041] and [0060]-[0061] & Fig. 2A-2B, 4A, and 7A-7B; annotated below in Fig. 7A as “1st Fluid Path”), and wherein the side port defines a second flow path extending from the side port into the body of the needle-free connector (first port 50 defines a second flow path extending from port 50 into the body of connector 48, [0041] and [0044] & Fig. 2A-2B, 4A, and 7A-7B; annotated below in Fig. 7A as “2nd Fluid Path”), wherein a center of the second flow path is offset from a center of the first flow path such that the center of the second flow path does not intersect the center of the first flow path (a center of the second flow path, annotated below in Fig. 7A as “2nd Center” of the “2nd Flow Path”, is illustrated as offset from a center of the first flow path, annotated below in Fig. 7A as “1st Center” of the “1st Flow Path”, such that the center of the second flow path does not intersect the center of the first flow path – the center of the second flow path is distal to the center of the first flow path);
intermediate tubing extending between the inlet of the catheter adapter and the first port of the needle-free connector (first extension tube 42 extending between side port 38 of catheter adapter 32 and port 64 of connector 48, [0041] and [0047] & Fig. 2A-2B and 6A); and extension tubing extending from the side port of the needle-free connector (second extension tube 54 extending from port 50 of connector 48, [0042] & Fig. 2A-2B); and
a blood draw device comprising a flow tube (instrument 80 comprising an additional catheter for blood draw, [0006], [0041], and [0057]-[0061] & Fig. 2A-2B and 3A-3B) configured to be extended through the needle-free connector, through the intermediate tubing, through the inlet of the catheter adapter, and through the catheter (“the first connector 48 and/or the second port 52 may be disposed in proximity to the catheter adapter 32 and the catheter 40 to improve access for an instrument… the instrument may include an additional catheter for fluid infusion or blood draw… a length of the first extension tube 42 may be about 12 millimeters… The length of the first extension tube 42 may vary, according to some embodiments.”, [0041] & Fig. 2A-2B; instrument 80 configured to be extended through connector 48, through tube 42 into catheter adapter 32, through side port 38, and necessarily through catheter 40 to facilitate blood withdrawal, [0057]-[0061]; “The present disclosure relates generally to devices, systems, and methods for facilitating delivery of an instrument and/or fluid through a catheter, which may include a peripheral intravenous catheter (PIVC).”, [0006]; also see [0064]; “…a connector 90 may include or correspond to the first connector 48… discussed with respect to FIGS. 2A-2B. In some embodiments, the connector 90 may not include any catch points for fluid or the instrument 80 moving through the connector 90 in the distal direction to enter the catheter adapter 32.”, [0061]). Blanchard discloses that the connector 48 is configured to be flushed ([0041] and [0056]).
However, Blanchard fails to explicitly disclose the needle-free connector wherein a radial center of the second flow path is offset from a radial center of the first flow path such that the radial center of the second flow path does not intersect the radial center of the first flow path.
However, Bihlmaier teaches a catheter adapter 300 with a side port 304, wherein the side port defines a second flow path extending from the side port into the body (side port 304 defines a flow path from port 304 into adapter 301, [0032]-[0036] & Fig. 3B), wherein a radial center of the second flow path is offset from a radial center of the first flow path such that the radial center of the second flow path does not intersect the radial center of the first flow path (“the longitudinal axis of side port 304 is… parallel to but spaced apart from this plane (FIG. 3B)… side port 304 so that its central axis is substantially parallel with but spaced from the central axis of catheter adapter 301 (by some non-inconsequential distance x) as shown in FIG. 3B… In some embodiments, a side port of a PIVC could be configured in accordance with both FIGS. 3A and 3B (i.e., the side port could be angled relative to and offset from the central axis of catheter adapter 301).”, [0033]-[0036] & Fig. 3A-3B; the radial center of the flow path defined by port 304 is offset from the radial center of the of the flow path defined by adapter 301 such that the radial centers do not intersect, Fig. 3B).
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 side port of Blanchard, with Bihlmaier, to include a radial center of the second flow path being offset from a radial center of the first flow path, such that the radial center of the second flow path does not intersect the radial center of the first flow path, since such a modification would maximize the amount of flushing that occurs within the interior of the adapter, “minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter” and yield predictable results pertaining to flushing efficiency (see [0005] and [0034-[0036] of Bihlmaier). As modified, first port 50 would be radially offset, like side port 304 of Bihlmaier.
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Regarding claim 3, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein a length of the intermediate tubing is shorter than a length of the extension tubing (“the second extension tube 54 may be longer than the first extension tube 42”, [0042] & Fig. 2A-2B).
Regarding claim 4, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein the intermediate tubing has a length configured to allow a probe of a blood draw device to extend a predetermined length beyond a tip of the catheter (“the first connector 48 and/or the second port 52 may be disposed in proximity to the catheter adapter 32 and the catheter 40 to improve access for an instrument… the instrument may include an additional catheter for fluid infusion or blood draw, a guidewire… a length of the first extension tube 42 may be about 12 millimeters. In some embodiments, the length of the first extension tube 42 may be between about 11 and 13 millimeters… The length of the first extension tube 42 may vary, according to some embodiments.”, [0041] & Fig. 2A-2B; length of tube 42 is configured to allow an instrument 80, which may be a catheter, or probe, configured for blood withdrawal, to extend beyond the tip of catheter 40, [0060] & Fig. 2A-2B, 3A, and 4A; “The devices, systems, and methods of the present disclosure may also be used for blood withdrawal”, [0006]).
Regarding claim 5, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system further comprising a medical component positioned at an end of the extension tubing (second connector 60 coupled to the proximal end 56 of tube 54, [0042] & Fig. 2A-2B).
Regarding claim 6, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein the intermediate tubing is fixedly connected to the inlet of the catheter adapter and the first port of the needle-free connector (connector 48, through port 64, may be permanently coupled to tube 42, [0047] and [0050] & Fig. 2A-2B; “the distal end 46 of the first extension tube 42 may be permanently… coupled to the catheter adapter 32.”, [0054] & Fig. 2A-2B).
Regarding claim 7, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein the first port of the needle-free connector is connected to the intermediate tubing via a line connector (connector 48 may be connected to tube 42 via snap mechanism 102, which is being interpreted as a line connector, [0065] & Fig. 7A-7B; “the first port 50, the second port 52, and the third port 64 of the first connector 48 may include any suitable type of coupling mechanism.”, [0047]).
Regarding claim 8, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein the needle-free connector comprises a body defining a longitudinal axis extending between the first port and the second port (connector 48 comprises a body defining a longitudinal axis between ports 64 and 52, [0042] & Fig. 2A-2B, 4A, and 7A), and wherein the side port extends from the body at an angle of 30-150 degrees relative to the longitudinal axis of the body (“the first port 50 may be disposed at an angle of less than 90° with respect to the second port 52, as illustrated, for example, in FIG. 2A. In further detail, in some embodiments, the first port 50 may be disposed at an angle between 45° and 90° with respect to the second port 52”, [0043]-[0044] & Fig. 2A-2B and 4A).
Regarding claim 10, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard further discloses the system wherein at least a portion of the needle-free connector is transparent (“the first connector 48… may be transparent,”, [0056]).
Regarding claim 12, Blanchard, as modified, discloses all the limitations of claim 1. Blanchard, as modified, further discloses the system wherein the needle-free connector comprises internal structure configured to create a vortex when fluid enters the needle-free connector via the side port (as modified, the internal, generally circular walls of connector 48 would be configured to create a swirling or spiraling flow of fluid when fluid enters connector 48 via radially offset first port 50, synonymous to the swirling or spiraling flow of fluid described as being achieved by side port 304 in Bihlmaier, [0034]-[0036] & Fig. 3A-3B of Bihlmaier).
Claim(s) 9 and 11 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1), in view of Bihlmaier (US 20190091462 A1), and further in view of Burkholz (US 20190021640 A1).
Regarding claim 9, Blanchard, as modified, discloses all the limitations of claim 8. However, Blanchard fails to explicitly disclose the system wherein the body of the needle-free connector comprises a first portion and a second portion connected to the first portion via a luer connector.
However, Burkholz teaches an integrated intravenous catheter (catheter assembly 14, [0040] & Fig. 1A/B) wherein the body of the needle-free connector (the body of adapter 32 and coupling mechanism 30, [0049] & Fig. 1B) comprises a first portion and a second portion connected to the first portion via a luer connector (adapter 32, which is being interpreted as a first portion, is coupled to mechanism 30, which is being interpreted as a second portion, via a luer connection, [0048]-[0049] & Fig. 1A-1C).
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 body of the needle-free connector of Blanchard, as modified, with Burkholz to include a first portion and a second portion connected to the first portion via a luer connector since such a modification would provide structure to facilitate connection to additional medical devices, such as a needle-free blood probe, an additional catheter, or a removable needle-free connector (see [0013], [0041], and [0048]-[0050] of Burkholz).
Regarding claim 11, Blanchard, as modified, discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose the system wherein the needle-free connector comprises an anti-reflux valve.
However, Burkholz teaches an integrated intravenous catheter (catheter assembly 14, [0040] & Fig. 1A/B) wherein the needle-free connector (adapter 32 and coupling mechanism 30, [0049] & Fig. 1B) comprises an anti-reflux valve (adapter 32 may include a blood control valve, [0049], this valve is being interpreted as an anti-reflux valve; alternatively, coupling mechanism 30 may include at least one valve which may be interpreted as an anti-reflux valve, [0050]).
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 needle-free connector of Blanchard, as modified, with Burkholz to include an anti-reflux valve since such a modification would “facilitate maintenance of the closed system and prevent blood leakage” or prevent fluid from the catheter from entering upstream components of the catheter assembly, like a blood collection device (see [0049]-[0050] of Burkholz).
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1), in view of Bihlmaier (US 20190091462 A1), and further in view of Funk (US 20190160275 A1).
Regarding claims 13-15, Blanchard, as modified, discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose the system wherein the needle-free connector comprises a stabilization member, wherein the stabilization member is formed either integrally with the needle-free connector or separately, configured to contact a skin surface of a patient during use of the integrated intravenous catheter.
However, Funk teaches an integrated intravenous catheter wherein a needle-free connector (coupler 215 and 220, of stabilizing connector 200, may both be needle free connectors, [0055] & Fig. 2 and 3) comprises a stabilization member, wherein the stabilization member is formed integrally with the needle-free connector (see [0036]), configured to contact a skin surface of a patient (stabilization portion 230 is configured to contact the skin of a patient, see [0056]) during use of the integrated intravenous catheter (stabilizing connector 200 is configured for use with a catheter, (see [0005]-[0006], [0041], and [0056]).
However, the embodiment of Figures 2-3 does not explicitly disclose the stabilization member separately connected to the needle-free connector. However, the embodiment of Figures 16-19 teaches the stabilization portion 430 formed separately from the connector portion 410 (see [0090]).
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 catheter of Blanchard, as modified, with Funk to include the needle-free connector comprising a stabilization member since such a modification would minimize movement of a placed or indwelling catheter and yield predictable results pertaining to device stabilization (see [0006], [0041], and [0054] of Funk).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the stabilization member 230 separately connected to connector 200, as taught in the alternate embodiment of Figures 16-19, since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Further, the Applicant is advised that patentability of a product does not depend on its method of production. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to Applicant’s arguments to the non-statutory double patenting rejection, the Examiner finds that claims 1 and 3-15 of application 17/898617 are unpatentable over claim 1 and 3-15 of copending Application No. 17898617 in view of Blanchard (US 20200078564 A1), as cited above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Philips (US 20200368413 A1) and Ray (US 20230181888 A1).
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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