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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a system, classified in A61M 2039/1077.
II. Claims 16-18, drawn to a method of flushing the integrated catheter, classified in A61B5/150992.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product can be used in a materially different process such as a process that requires drawing blood or introducing intravenous fluid, medication, etc.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventive groups have acquired a separate status in the art in view of their different classification, see above;
(b) the inventive groups have acquired a separate status in the art due to their recognized divergent subject matter: The inventive groups contain divergent subject matter; and/or
(c) the inventive groups require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries): The divergent subject matter of the inventive groups would require different search strategies and search queries.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Attorney Adam Komorowski on April 22nd 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 5 is objected to because of the following informalities:
Regarding claim 5, “a medical connector” should be corrected to “a medical component” to align with specification terminology, see [0044] – medical component 36.
Appropriate correction is required.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of copending Application No. 17898617 in view of Blanchard (US 20200078564 A1). Claim 1 of 17898617 teaches all the limitations of claims 1-2 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blanchard (US 20200078564 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, [0040], and [0043] & 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);
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]).
Regarding claim 2, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the system wherein the needle-free connector comprises a body defining a 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 or blood withdrawal, see [0041] and [0060]-[0061] & Fig. 2A-2B, 4A, and 7A-7B), and wherein the side port is offset from a center of the flow path (first port 50 seen offset from a center of the fluid pathway between ports 64 and 52, see Fig. 7A; side port 50 seen entering distal to a center of the fluid pathway between the proximal and distal ports).
Regarding claim 3, Blanchard 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 discloses all the limitations of claim 1. Blanchard further discloses the system wherein the intermediate tubing has a length configured to allow the flow tube of the 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 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 the additional catheter, instrument 80, to extend beyond the tip of catheter 40 to facilitate blood withdrawal, [0060]-[0061] & Fig. 2A-4A; ““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]).
Regarding claim 5, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the system further comprising a medical connector 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 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 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 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 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]).
Claim(s) 9 and 11 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Burkholz (US 20190021640 A1).
Regarding claim 9, Blanchard 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 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 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 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) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Bihlmaier (US 20190091462 A1).
Regarding claim 12, Blanchard discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose 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.
However, Bihlmaier teaches a catheter adapter 201 with a side port 204 that includes an internal flow diverting protrusion 210a that can be curved in a spiral to impart a spiraling pattern to the resulting eddy from fluid flowing through side port 204 (see [0026]-[0030] & Fig. 2B).
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 internal structure of the needle-free connector of Blanchard with Bihlmaier to include the internal flow diverting protrusion since such a modification would “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 [0028] of Bihlmaier).
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Funk (US 20190160275 A1).
Regarding claims 13-15, Blanchard 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 system of Blanchard 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.
Conclusion
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.
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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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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