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
This Office Action is in response to the Applicant’s amendment filed 26 February 2026 wherein Claims 1 and 2 are amended, Claims 3 and 5 are cancelled, and Claims 18 and 19 are newly added. Therefore Claims 1, 2, 6 – 14, and 17 – 19 are currently pending.
The Applicant’s amendments to the Claims has overcome each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and (b) within the Non-Final Rejection dated 27 August 2025. Therefore each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and (b) are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 6 – 8, filed 26 February 2026, with respect to the rejection(s) of independent claim 1 and its respective dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Daga (US 2005/0277879 A1), Christensen (US 2010/0042048 A1), Gupta (WO 2016/063287 A1), and Bialecki et al. (US 2007/0191776 A1).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 6, 9 – 11, 13, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daga (US 2005/0277879 A1) in view of Christensen (US 2010/0042048 A1), Gupta (WO 2016/063287 A1), and Bialecki et al. (US 2007/0191776 A1; hereinafter referred to as “Bialecki”).
Christensen and Gupta are each cited in the Notice of References Cited form dated 1 October 2024.
With regards to claim 1, Daga discloses (Figs. 1 –2 and 9 – 10) an intravenous catheter comprising:
a catheter tube (26) (see [0033]) having a proximal end and a distal end (see Fig. 2 where the distal end is near 22 and the proximal end is near 14);
a catheter hub (14) (see [0030]) having an inner chamber (see at 14 in Fig. 2) in fluid connection with the catheter tube forming a first fluid pathway (see [0033] and Fig. 2), the catheter hub having a distal end (see at 14 in Fig. 2) connected to the proximal end of the catheter tube (see [0033]) having a first bore (see Fig. 2 at 26 and [0033]); and
a needle (20) (see [0032]) having a proximal end (see the end of the needle 20 that is attached to the needle hub 18 in Fig. 2), a tip (22) (see [0031]) at a distal end (see at 22 in Fig. 2 and Fig. 10), and an enlarged dimension feature (23) (see [0041]) towards the distal end of the needle (see Fig. 10), the needle adapted to extend along a length of the first bore of the catheter tube (see Fig. 2 and [0033]), the needle hub connected to a flashback chamber (24) (see [0032]) through an extended portion of the needle hub (see the portion of the needle hub 18 that the flashback chamber 24 extends into in Fig. 2),
wherein the tubular sleeve (see at 48 in Fig. 9) defines an axially oriented radially inward extending slit (see at 48 in Fig. 9 where the slit extends between the jaws 48) and a second bore (see at 44 in Fig. 9 where the bore extends from the base 42 to past the tension ring 53)) both extending to a distal end of the tubular sleeve (see near 53 in Fig. 9) for receiving the needle, wherein the enlarged dimension feature of the needle has an enlarged dimension feature diameter (see [0041] “The needle 20 has a flare positioned near its needle point 22 so that its effective diameter increases at that particular point…The flare 23 ensures that the needle safety device 40 will not be pulled out once the needle tip 22 is trapped in the needle safety device 40.”) that is greater than a diameter of the second bore such that when the needle is retracted from the needle cover through the second bore (see [0041] and Figs. 9 – 10), the second bore remains open at the distal end of the tubular sleeve (see Fig. 10 where the bore is shown to remain open at the distal end of the tubular sleeve), and the slit remains open but contracts radially (see [0043] “the jaws 48 made of a flexible material…are permitted to flex slightly to pass the obstruction 34”), causing the needle cover to disengage the catheter hub (see [0043] and [0044]), wherein the slit spans a diameter of the tubular sleeve extending through the second bore from a first portion of an outer surface of the tubular sleeve to a second portion of the outer surface of the tubular sleeve (see Figs. 9 – 11), the first portion separate from the second portion (see Figs. 9 – 11).
Daga is silent with regards to following:
the catheter being formed of flexible plastic;
the catheter hub comprising dotted projections intermittently protruding toward the inner chamber from an inner surface of the catheter hub;
the proximal end of the needle being press fitted in a needle hub;
wherein a tubular sleeve of a needle cover defines a recess matching a profile of the dotted projections of the catheter hub, wherein the tubular sleeve of the needle cover is reversibly locked to the catheter hub via engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve,
wherein the needle cover having the tubular sleeve with the slit and the second bore is adapted to receive the needle such that when the needle is inserted into the needle cover, the enlarged dimension feature of the needle having the enlarged dimension feature diameter that is greater than the diameter of the second bore pushes the slit outwardly for locking of the needle cover with the catheter hub via the engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve;
wherein the dotted projections and the recess are offset from the distal end of the tubular sleeve.
Nonetheless Christensen, which is within the analogous art of the intravenous catheters (see Abstract), teaches (Fig. 1) the catheter tube (14) is made of flexible plastic (see [0029] “catheter 14 made from polyurethane”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the catheter tube of the intravenous catheter of Daga with a teaching of Christensen such that the catheter tube is made of flexible plastic. One of ordinary skill in the art would have been motivated to make this modification because Daga is silent with regards to the material of the catheter tube. Therefore, one of ordinary skill in the art would refer to Christensen to determine what material the catheter tube can be made of. Additionally, it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07.
The intravenous catheter of Daga modified in view of a teaching of Christensen will hereinafter be referred to as the intravenous catheter of Daga and Christensen.
Neither Daga nor Christensen teach the following:
the catheter hub comprising dotted projections intermittently protruding toward the inner chamber from an inner surface of the catheter hub;
the proximal end of the needle being press fitted in a needle hub;
wherein a tubular sleeve of a needle cover defines a recess matching a profile of the dotted projections of the catheter hub, wherein the tubular sleeve of the needle cover is reversibly locked to the catheter hub via engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve,
wherein the needle cover having the tubular sleeve with the slit and the second bore is adapted to receive the needle such that when the needle is inserted into the needle cover, the enlarged dimension feature of the needle having the enlarged dimension feature diameter that is greater than the diameter of the second bore pushes the slit outwardly for locking of the needle cover with the catheter hub via the engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve;
wherein the dotted projections and the recess are offset from the distal end of the tubular sleeve.
Nonetheless Gupta, which is within the analogous art of intravenous catheters (abstract), teaches (Figs. 1-4D) the proximal end of the needle (1) being press fitted in a needle hub (2; see Page 11, lines 22-28 “The needle hub 2 includes a through hole 13 in which the needle 1 may be press fitted”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the proximal end of the needle of the intravenous catheter of Daga and Christensen in view of a teaching of Gupta such that the proximal end of the needle is press fitted in a needle hub. One of ordinary skill in the art would have been motivated to make this modification because Daga is silent with regards to the specific attachment between the proximal end of the needle and the needle hub. Therefore, one of ordinary skill in the art would refer to a teaching of Gupta in order to determine how the proximal end of the needle may be connected with the needle hub (i.e. press fitted).
The intravenous catheter of Daga and Christensen modified in view of a teaching of Gupta will hereinafter be referred to as the intravenous catheter of Daga, Christensen, and Gupta.
However none of Daga, Christensen, and Gupta teaches the following:
the catheter hub comprising dotted projections intermittently protruding toward the inner chamber from an inner surface of the catheter hub;
the proximal end of the needle being press fitted in a needle hub;
wherein a tubular sleeve of a needle cover defines a recess matching a profile of the dotted projections of the catheter hub, wherein the tubular sleeve of the needle cover is reversibly locked to the catheter hub via engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve,
wherein the needle cover having the tubular sleeve with the slit and the second bore is adapted to receive the needle such that when the needle is inserted into the needle cover, the enlarged dimension feature of the needle having the enlarged dimension feature diameter that is greater than the diameter of the second bore pushes the slit outwardly for locking of the needle cover with the catheter hub via the engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve;
wherein the dotted projections and the recess are offset from the distal end of the tubular sleeve.
Nonetheless Bialecki, which is within the analogous art of enclosed needle devices with duckbill release mechanisms (see abstract and title), teaches (see Figs. 4 – 7) the catheter hub (16) (see [0022]) comprising dotted projections (25) (see [0022] “an annular rib 25 (which may be a single rib or one or more arcuate segments” wherein the one or more arcuate segments are the dotted projections) intermittently protruding toward the inner chamber (24) (see [0022]) from an inner surface (23) (see [0022])of the catheter hub;
wherein a tubular sleeve (50) (see [0025]) of a needle cover (42) (see [0025]) defines a recess (58) (see [0025]) matching a profile of the dotted projections of the catheter hub (see [0025] “the recess(es) 58 define an area into which rib 25 is removably received without compressing, or only slightly compressing, the arm(s) 52, 53”), wherein the tubular sleeve of the needle cover is reversibly locked to the catheter hub via engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve (see [0025] “a duckbill release mechanism”),
wherein the needle cover having the tubular sleeve with the slit (see at 120 in Fig. 7) and the second bore (see at 54 in Fig. 7) is adapted to receive the needle (34) (see [0025]) such that when the needle is inserted into the needle cover (se Figs. 6A – 6E);
wherein the dotted projections and the recess are offset from the distal end of the tubular sleeve (see Figs. 4 and 5 which shows the dotted projections 25 and the recess 58 being offset from the distal end of the tubular sleeve 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the obstruction 34 of the catheter hub 14 and the recess on the tubular sleeve of the needle cover 40 of the intravenous catheter of Daga, Christensen, and Gupta in view of a teaching of Bialecki such that the catheter hub comprising dotted projections intermittently protruding toward the inner chamber from an inner surface of the catheter hub; the proximal end of the needle being press fitted in a needle hub; wherein a tubular sleeve of a needle cover defines a recess matching a profile of the dotted projections of the catheter hub, wherein the tubular sleeve of the needle cover is reversibly locked to the catheter hub via engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve, wherein the needle cover having the tubular sleeve with the slit and the second bore is adapted to receive the needle such that when the needle is inserted into the needle cover; wherein the dotted projections and the recess are offset from the distal end of the tubular sleeve.
One of ordinary skill in the art would have been motivated to make this modification because Bialecki teaches that a needle cover can be releasably coupled to a catheter hub via a single rib or one or more arcuate segments (see [0022] of Bialecki). Bialecki teaches that this structure forms a duckbill release mechanism which is advantageous due to its strong hold when a needle is present and its easy release when the needle is not present (see [0007] and [0008] of Bialecki).
The intravenous catheter of Daga, Christensen, and Gupta modified in view of a teaching of Bialecki will hereinafter be referred to as the intravenous catheter of Daga, Christensen, Gupta, and Bialecki.
The intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the enlarged dimension feature (23 of Daga) of the needle (20 of Daga) having the enlarged dimension feature diameter that is greater than the diameter of the second bore (see at 44 in Fig. 10 of Daga) pushes the slit (see at 48 in Fig. 9 where the slit extends between the jaws 48 of Daga) outwardly for locking of the needle cover with the catheter hub (14 of Daga and see [0037] “two jaws 48 moveable between an expanded position with the effective outer diameter of the jaws increased when the needle 20 is between the jaws 48”) via the engagement of the dotted projections of the catheter hub with the recess defined by the tubular sleeve (see the modification of Daga in view of a teaching of Bialecki above).
With regards to claim 2, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however, Daga is silent with regards to wherein the recess is a groove or cavity on the outer surface of the tubular sleeve.
Nonetheless Bialecki, which is within the analogous art of enclosed needle devices with duckbill release mechanisms (see abstract and title), teaches (see Figs. 4 – 7) the recess (58) (see [0025]) is a groove or cavity (see at 58 in Fig. 5) on the outer surface of the tubular sleeve (50) (see [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the recess of the tubular sleeve of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki in view of a further teaching of Bialecki such that the recess is a groove or cavity on the outer surface of the tubular sleeve. One of ordinary skill in the art would have been motivated to make this modification because Bialecki teaches that a needle cover can be releasably coupled to a catheter hub via a single rib or one or more arcuate segments (see [0022] of Bialecki). Bialecki teaches that this structure forms a duckbill release mechanism which is advantageous due to its strong hold when a needle is present and its easy release when the needle is not present (see [0007] and [0008] of Bialecki).
With regards to claim 6, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, and Daga further teaches (Figs. 1 –2 and 9 – 10) wherein the catheter hub (14) (see [0030]) comprises an outer port (see at 16 in Fig. 2) abutting on an outer surface of the catheter hub forming a second fluid pathway (see Fig. 2 where the second fluid pathway is through the outer port at 16 in Fig. 2), wherein the second fluid pathway is in fluid communication with the first fluid pathway (see [0033] and Fig. 2 where the first fluid pathway is from the proximal end of the catheter hub through the catheter tube 26) .
With regards to claim 9, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to the intravenous catheter further comprising an elongated tube connected to the extended portion of the needle hub and defining a second fluid pathway in fluid communication with the first fluid pathway.
Nonetheless Christensen, is which is within the analogous art of intravenous catheters, further teaches (Fig. 1) an elongated tube (16) connected to the extended portion (see Examiner annotated Fig. 1 below, hereinafter referred to as Fig. C) of the needle hub (26) and defining a second fluid pathway (see Fig. C below) in fluid communication with the first fluid pathway (see Fig. C below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle hub of the intravenous catheter of the Daga, Christensen, Gupta, and Bialecki with a further teaching of Christensen such that the intravenous catheter further comprises an elongated tube connected to the extended portion of the needle hub and defining a second fluid pathway in fluid communication with the first fluid pathway. The catheter hub of Daga would be modified to incorporate a side port onto its outer surface similar to how the side port is located on the outer surface of the catheter hub of Christensen (see Fig. 1 of Christensen). After incorporating a side port onto the outer surface of the catheter hub of Daga an elongated tube 16, Y adaptor 18, and the extravascular system 10 of Christensen would be attached/coupled to the side port. Thereby creating an intravenous catheter comprising an elongated tube connected to an extended portion of the needle hub and defining a second fluid pathway in fluid communication with the first fluid pathway. One of ordinary skill in the art would have been motivated to make this modification, as modifying the catheter to include a side port, an elongated tube, a Y adaptor, and an extravascular system allows for attachment of further infusion sets for infusion therapy and for attachment of a vent plug (see [0030-0031] of Christensen).
With regards to claim 10, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 9, however Daga is silent with regards to wherein the elongated tube comprises an inner chamber with a first end and a second end, such that the second end is configured to be connected to the extended portion of the needle hub.
Nonetheless, Christensen which is within the analogous art of intravenous catheters, further teaches (Figs. 1-4) the elongated tube (16) comprises an inner chamber (see the lumen of the catheter tube 16 shown in Fig. 4) with a first end (see Fig. C above) and a second end (see Examiner annotated Fig. 4 below; hereinafter referred to as Fig. D below), such that the second end is configured to be connected to the extended portion of the needle hub (see Fig. 4 which shows the second end being configured to connect to the extended portion of the needle hub, as annotated in Fig. C above).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the intravenous catheter of Daga, Christensen, Gupta, and Bialecki with a further teaching of Christensen such that the elongated tube comprises an inner chamber with a first end and a second end, such that the second end is configured to be connected to the extended portion of the needle hub. One of ordinary skill in the art would have been motivated to make this modification, as modifying the catheter to include an elongated tube, Y adaptor, and extravascular system allows for attachment of further infusion sets for infusion therapy and for attachment of a vent plug (see [0030-0031] of Christensen).
With regards to claim 11, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to wherein the flashback chamber comprises a hydrophobic filter.
Nonetheless, Gupta which is within the analogous art of intravenous catheters (abstract), further teaches (Figs. 1-4D) the flashback chamber (11) comprises a hydrophobic filter (see page 9, lines 1-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the flashback chamber of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki with a further teaching of Gupta such that the flashback chamber comprises a hydrophobic filter. One of ordinary skill in the art would have been motivated to make this modification, in order to allow air to escape through the flashback chamber while allowing blood to flow in the flashback chamber (see page 9, lines 1-15 of Gupta).
With regards to claim 13, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to wherein the needle cover is connected to a casing, the casing being detachably connected to the needle cover via one or more ribs and to the needle hub via one or more hooks inserted into one or more slots of the needle hub.
Nonetheless Gupta, which is within the analogous art of intravenous catheters (see abstract), teaches (Figs. 1a-4d) the needle cover (24) is connected to a casing (30), the casing being detachably connected to the needle cover via one or more ribs (23) (See Page 9, lines 26-27 “The needle cover 24 includes…and third first zone03” note there is a typographical error within this passage as the “and third first zone03” should read “and third zone 103” and Page 11, lines 18-21 “The third zone 103 further may have projections 23 at is circumference, which makes connection with the casing 30”) and to the needle hub (2) via one or more hooks (18) inserted into one or more slots (15) of the needle hub (See Page 12, lines 1-5 “the casing makes an engaging connection with the needle hub 2 via…locking the hooks 18 in the corresponding slots 15 as shown in figure 4d.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the intravenous catheter of Daga, Christensen, Gupta and Bialecki in view of a further teaching of Gupta such that the needle cover is connected to a casing, the casing being detachably connected to the needle cover via one or more ribs and to the needle hub via one or more hooks inserted into one or more slots of the needle hub. One of ordinary skill in the art would have been motivated to make this modification because Gupta teaches that upon removal of the needle and needle cover/guard from the catheter hub both the needle and needle cover/guard are enclosed within the casing. Thereby, further implementing a needle stick safety mechanism that is simple and easy to use (see page 11, line 22 – page 12, line 15 of Gupta).
With regards to claim 14, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, and Daga further teaches (Figs. 1 –2 and 9 – 10) wherein the needle is a hypodermic needle (see [0001] – [0002] and [0033]) and the tip of the needle is bevelled (see [0032] “the needle tip 22 is typically cut at a diagonal”).
With regards to claim 17, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to wherein the slit has a constant width when unoccupied by the needle.
Nonetheless Bialecki, which is within the analogous art of enclosed needle devices with duckbill release mechanisms (see abstract and title), teaches (see Figs. 4 – 7) the slit (see at 120 in Fig. 7) has a constant width when unoccupied by the needle (34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of the slit of the tubular sleeve of the needle cover of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki in view of a further teaching of Bialecki such that the slit has a constant width when unoccupied by the needle. One of ordinary skill in the art would have been motivated to make this modification because Bialecki teaches that a needle cover can be releasably coupled to a catheter hub via a single rib or one or more arcuate segments (see [0022] of Bialecki). Bialecki teaches that this structure forms a duckbill release mechanism which is advantageous due to its strong hold when a needle is present and its easy release when the needle is not present (see [0007] and [0008] of Bialecki). Additionally, it would have been an obvious matter of design choice to modify the shape of the slit such that the slit has a constant width when unoccupied by the needle, since such a modification would have involved a mere change in the form or shape of a component. It has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
Claim(s) 7 – 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daga, Christensen, Gupta, and Bialecki as applied to claim 6 above, and further in view of Payne (US 2004/0168690 A1).
Payne is cited in the Notice of References Cited form dated 1 October 2024.
With regards to claim 7, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 6, however Daga is silent with regards to wherein the outer port is provided with a dispensing cap in which a hinge of the dispensing cap has a spring action.
Nonetheless, Payne which is within the analogous art of closure devices for use with an access port (see abstract), teaches (Figs. 1-6) that the outer port (28) is provided with a dispensing cap (14) in which a hinge (13) of the dispensing cap has a spring action (see [0016-0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the dispensing cap of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki with a teaching of Payne such that the outer port is provided with a dispensing cap in which a hinge of the dispensing cap has a spring action. One of ordinary skill in the art would have been motivated to make this modification, as a hingedly mounted cap is guided into an out of engagement with the access port. Thereby, reducing the risk of the cap not being placed properly or being detached and lost (see [0111] of Payne).
The intravenous catheter of Daga, Christensen, Gupta, and Bialecki modified in view of a teaching of Payne will hereinafter be referred to as the intravenous catheter of Daga, Christensen, Gupta, Bialecki, and Payne.
With regards to claim 8, the intravenous catheter of Daga, Christensen, Gupta, Bialecki, and Payne teaches the claimed invention of claim 7, however Daga is silent with regards to wherein the dispensing cap and the outer port are connected together by the hinge urging the dispensing cap to freely swing to a fully open or a fully closed position when pushed in respective directions.
Nonetheless, Payne which is within the analogous art of closure devices for use with an access port, further teaches (Figs. 1-6) the dispensing cap (14) and the outer port (28) are connected together by the hinge (13) urging the dispensing cap to freely swing to a fully open or a fully closed position when pushed in respective directions (see [0016] “the cap is urged by a user away from either the open or closed position”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter of Daga, Christensen, Gupta, Bialecki and Payne with a further teaching of Payne such that the dispensing cap and the outer port are connected together by the hinge urging the dispensing cap to freely swing to a fully open or a fully closed position when pushed in respective directions. One of ordinary skill in the art would have been motivated to make this modification, as a hinged mechanism provides the cap with a positive opening and closing action which speeds up the opening and closing of the cap, and reduces the risk of the cap being inadvertently displaced from either the open or the closed position (see [0017] of Payne).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daga, Christensen, Gupta, and Bialecki as applied to claim 1 above, and further in view of Woehr et al. (US 2016/0175563; hereinafter referred to as “Woehr ‘563”).
Woehr ‘563 is cited in the Notice of References Cited form dated October 1, 2024.
With regards to claim 12, the intravenous catheter of Daga, Christensen, Gupta, Bialecki, and Payne teaches the claimed invention of claim 1, however Daga is silent with regards to further comprising a rigid conical guide member abutting a disc in the catheter hub, wherein the disc is made of silicone.
Nonetheless, Woehr ‘563 which is within the analogous art of intravenous catheters, teaches (Fig. 1) a rigid conical guide member (104) abutting a disc (122) in the catheter hub (101) wherein the disc is made of silicone (see [0113] “the valve 122 can comprise silicone, silicone rubber”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter of Daga, Christensen, Gupta, and Bialecki with a teaching of Woehr ‘563 such that the intravenous catheter further comprises a rigid conical guide member abutting a disc in the catheter hub wherein the disc is made of silicone. One of ordinary skill in the art would have been motivated to make this modification, as the valve may limit the fluid flow through the catheter hub (see [0082] of Woehr).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daga, Christensen, Gupta, and Bialecki as applied to claim 1 above, and further in view of Steube (US 2012/0277679 A1).
With regards to claim 18, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to wherein the enlarged dimension feature of the needle comprises an annular ring protruding from an outer surface of the needle.
Nonetheless Steube, which is within the analogous art of safety IV catheter assemblies (see abstract and title)¸teaches the enlarged dimension feature (32) (see [0027]) of the needle (22) (see [0027]) comprises an annular ring (see [0027] “the enlarged diameter portion 32 may be formed on needle 22 using other known techniques including welding a ring or bead onto or about the needle 22.”) protruding from an outer surface of the needle (see Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the flare 23 of the needle of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki in view of a teaching of Steube such that the enlarged dimension feature of the needle comprises an annular ring protruding from an outer surface of the needle. One of ordinary skill in the art would have been motivated to make this modification because Steube teaches that an annular ring shape is well known for forming the enlarged diameter portion’s shape (see [0027] of Steube). Additionally, it would have been an obvious matter of design choice to modify the shape of the enlarged dimension feature of the needle of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki in view of Steube such that the enlarged dimension feature of the needle comprises an annular ring protruding from an outer surface of the needle, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daga, Christensen, Gupta, and Bialecki as applied to claim 1 above, and further in view of Woehr et al. (US 2003/0060774 A1; hereinafter referred to as “Woehr ’774”).
With regards to claim 19, the intravenous catheter of Daga, Christensen, Gupta, and Bialecki teaches the claimed invention of claim 1, however Daga is silent with regards to wherein the enlarged dimension feature of the needle comprises a helical ring protruding from an outer surface of the needle.
Nonetheless Woehr, which is within the analogous art of spring launched needle safety clips (see abstract and title), teaches the enlarged dimension feature of the needle can be formed in any shape suitable to prevent the needle from being withdrawn from the needle cover (see [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the enlarged dimension feature of the needle of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki in view of a teaching of Woehr such that the enlarged dimension feature of the needle comprises a helical ring protruding from an outer surface of the needle. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches that the enlarged dimension feature can be formed in any shape suitable to prevent the needle from being withdrawn from the needle cover (see [0039]). Here the Applicant’s Specification is silent with regards to why a helical ring would be more beneficial than any of the other shapes of the enlarged dimension feature. Therefore it would have been an obvious matter of design choice to modify the shape of the enlarged dimension feature of the intravenous catheter of Daga, Christensen, Gupta, and Bialecki such that the enlarged dimension feature of the needle comprises a helical ring protruding from an outer surface of the needle, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
Conclusion
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
05/12/2026
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