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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8 May 2025 has been entered.
The Examiner acknowledges the amendments to claims 1, 3, 8, and 12, as well as the cancellation of claims 19-21. Claims 1, 3, 6-12, and 17-18 are pending.
Claim Objections
Claim(s) 12 is/are objected to because of the following informalities:
Claim 12 should read “wherein the [[a]] catheter extends distally from the catheter adapter” [lines 3-4].
Claim 12 should read “blood collection container” [lines 18, 24-25, 26-27].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 12 and those dependent therefrom is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation “wherein when the slit is in the closed state fluid is prevent from flowing through the lumen” [lines 13-14], which is considered indefinite, as claim 12 also recites “a plurality of holes within the distal end in fluid communication with the lumen and proximal to the slit” [lines 21-22], such that it is unclear how the slit [in the closed state] may prevent fluid from flowing through the lumen when the plurality of holes are also in fluid communication with the lumen, as fluid may flow through the lumen via the plurality of holes. For examination purposes, the Examiner has interpreted the recitation of “wherein when the slit is in the closed state fluid is prevent from flowing through the lumen” [lines 13-14] to read “wherein when the slit is in the closed state fluid is prevent from flowing through the lumen via the slit”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 7, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190021640-A1, cited by Applicant in IDS dated 7 June 2021) in view of Chevillon (FR-2707505-A1, translation attached to original document), and Engel (US-20050015072-A1).
Regarding claim 1, Burkholz teaches
A delivery system comprising:
a delivery device comprising a housing [housing 28 (Burkholz Figure 1A)] and configured to couple to a catheter adapter [catheter adapter 20 (Burkholz Figure 1A)] at a proximal end of the catheter adapter [the second lumen of the catheter adapter 20 may be coupled with the extension 10 via the extension tube 22 that may extend from the second port 26 of the catheter adapter 20 (Burkholz ¶0045); the extension 10 may include a barrel or housing 28 (Burkholz ¶0048)];
the catheter adapter configured to couple to a catheter at a distal end of the catheter adapter [the catheter 16 may be secured within and extend distally from the catheter adapter 20 (Burkholz ¶0043, Figure 1A)];
a tubular instrument [instrument 12 (Figures 1A-C), wherein as depicted in Figures 1A-C, the instrument 12 is considered to be tubular] configured to be inserted through the housing of the delivery device, the catheter adapter, and the catheter [Burkholz Figures 1A-C];
the tubular instrument comprising a distal end [distal portion 41 (Burkholz Figure 1C)], a proximal end [proximal portion 43 (Burkholz Figure 1C)], and a lumen extending between the distal end and the proximal end [the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055, Figure 1B-C); the instrument 12 may then be advanced through the fluid pathway of the catheter assembly 14 and/or the distal tip 42 of the instrument may be placed into the vasculature distal to the tip 18 of the catheter 16. In some embodiments, following the advancement of the instrument, the syringe 54, which may be pre-filled, may be used to flush the catheter assembly 14 to remove stagnant blood and/or medication. In some embodiments, a plunger of the syringe 54 may be pulled to withdraw a discard sample. In some embodiments, the blood collection tube 48 may be coupled with the adapter 36 to obtain a blood sample (Burkholz ¶0068), wherein holes configured to allow for fluid flow into or out of the instrument 12, wherein the fluid is collected into a blood collection tube 48 connected to the instrument 12 or flushed through the instrument 12 from a syringe, is considered to define the claimed lumen], wherein the distal end comprises a distal tip [distal tip 42 (Burkholz Figures 1B-C)], wherein the tubular instrument is configured to advance distally with respect to the housing [the extension 10 or introducer may be configured to introduce the instrument 12 into a catheter assembly 14. In some embodiments, when the instrument 12 is introduced into the catheter assembly 14, the instrument 12 may access a fluid pathway of the catheter assembly 14 and/or the instrument may extend through the catheter assembly 14 and access vasculature of a patient (Burkholz ¶0040, Figure 1A)];
a blood collection device [adapter 36 (Burkholz Figures 1-2)] in fluid communication with the lumen of the tubular instrument [the extension 10 may include an adapter 36, which may be coupled to a proximal end of the instrument 12 (Burkholz ¶0053, Figures 1-2); the adapter 36 may include a cavity configured to receive, for example, a syringe and/or blood collection tube (Burkholz ¶0054, Figure 2D)], wherein the housing of the delivery device defines a slot extending longitudinally between a distal end of the housing and a proximal end of the housing [the housing 28 may include a slot 34, which may extend parallel to a longitudinal axis of the housing 28 (Burkholz ¶0051, Figure 1A)], wherein the blood collection device connects to the proximal end of the tubular instrument through the slot [Burkholz Figures 1A-C], and wherein the blood collection device is configured to advance distally with respect to the housing in unison with the tubular instrument [the adapter 36 may be configured to move along the slot 34 from a proximal position to a distal position and/or from the distal position to the proximal position. In some embodiments, in response to movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28 (Burkholz ¶0053, Figures 1A-C)].
However, while Burkholz discloses wherein the tubular instrument comprises inlet and/or outlet holes at the distal tip [the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055, Figure 1B-C)], Burkholz fails to explicitly disclose a pressure-sensitive valve comprising a cross slit disposed at a distal-most portion of the distal tip and at a distal end of the lumen, wherein the pressure-sensitive valve is configured to move from a closed position to an open position in response to a negative pressure differential within the lumen being within a predetermined pressure window.
Chevillon discloses a tubular instrument comprising a distal end, a proximal end, and a lumen extending between the distal end and the proximal end [a catheter capable of being introduced into a blood vessel in particular of a human body. This catheter has a proximal end 1a and an opposite distal end 1b, in this case having a rounded end 1c. As illustrated, this catheter consists of a catheter tube 10, enclosing an internal conduit 3, extending along the axis 10a of the tube, between its two opposite ends (Translated Chevillon p. 3, Figure 1)], wherein the tubular instrument further comprises a pressure-sensitive valve comprising a cross slit disposed at a distal-most portion of the distal tip and at a distal end of the lumen [the valve could also consist of a slot extending essentially transverse to the axis of the conduit of the catheter tube. This slot can in particular have the form of a "linear" line. But we could also consider a curve conformation, or even other. Instead of a single slot, it has also been imagined the possibility of conforming the valve like a cross or even a star with at least three branches (Chevillon p. 3, Figures 6-7); in the version of FIGS. 6 and 7, or the front valve, identified here 11 ′, has the shape of a star with four branches (or cross), this shape having been obtained by simple cutting, along two perpendicular axes 10a, 10'a, of the rounded end wall 13 of the tube 10 (Chevillon p. 5, Figures 6-7)], wherein the pressure-sensitive valve is configured to move from a closed position to an open position in response to a negative pressure differential within the lumen being within a predetermined pressure window [While at its proximal end the tube is open on the diameter of its internal conduit, its opposite end 1b is normally closed, while nevertheless having, substantially in the axis 10a, a two-way valve 5, arranged through the thickness of the front end wall lc of the tube to communicate on one side with the outside and on the other with the conduit 3, so that, when a predetermined pressure differential exists between the inside and Outside the tube, the valve can open, thereby defining a temporary liquid inlet or outlet port (Chevillon p. 4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz to employ a pressure-sensitive valve comprising a cross slit disposed at a distal-most portion of the distal tip and at a distal end of the lumen, wherein the pressure-sensitive valve is configured to move from a closed position to an open position in response to a negative pressure differential within the lumen being within a predetermined pressure window, so as to prevent local weakening of the wall of the tubular instrument [this frontal or facial arrangement of the valve must reduce the risk of local weakening of the wall of the catheter tube (Chevillon p. 2)] and allow for controlled fluid inflow into the lumen [in the absence of vacuum inside the duct 3, controlled, for example, by a puncture, the front valve 5 will remain closed, thus preventing in particular that blood can unexpectedly penetrate inside the tube, then risking coagulation if no anti-coagulant product, such as "Heparin" is used, this possible coagulation of the blood requiring, in any case, a cleaning of the catheter after each use (Chevillon p. 4)].
However, while Burkholz discloses that the distal tip may be constructed of a softer and/or less rigid material than the proximal end of the tubular instrument [the distal tip 42 may be constructed of a softer and/or less rigid material than the proximal end of the instrument 12 for buckling resistance (Burkholz ¶0055)], as well as the tubular instrument having variable stiffness along the length of the tubular instrument [Additionally or alternatively, the instrument 12 may have variable stiffness along a length of the instrument 12 (Burkholz ¶0056)], Burkholz in view of Chevillon fails to explicitly disclose wherein the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen and proximal to the pressure-sensitive valve.
Engel discloses a tubular instrument, wherein Engel discloses that the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen [apertures 22 are disposed such that the major axis 38 is at a right angle to the longitudinal axis 28 of lumen 18… apertures 22 may be oriented such that major axis 38 is perpendicular to longitudinal axis 28 at locations where the cannula 10 exhibits the greatest degree of bending during use in surgery, and therefore presents the greatest need for buckle-resistant apertures (Engel ¶0028, Figures 3-4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery system of Burkholz in view of Chevillon to employ a plurality of holes within the distal end in fluid communication with the lumen and proximal to the pressure-sensitive valve, in order to allow for increased flexibility of the tubular instrument while preventing buckling [Engel ¶0028, Figure 1].
Regarding claim 3, Burkholz in view of Chevillon and Engel teaches
The delivery system of claim 1, wherein the pressure-sensitive valve is monolithically formed with the tubular instrument as a single unit [wherein the slit being formed via a cut in the tubular instrument itself is considered to read on the claimed limitation (Chevillon p. 5)].
Regarding claim 7, Burkholz in view of Chevillon and Engel teaches
The delivery system of claim 1, wherein a length of the cross slit extends only partially across a width of the distal end [Chevillon Figure 7].
Regarding claim 12, Burkholz teaches
A method of blood collection, comprising:
inserting a catheter of a catheter assembly into vasculature of a patient [insertion of the catheter 16 into the vasculature of the patient (Burkholz ¶0045)], wherein the catheter assembly comprises a catheter adapter [catheter adapter 20 (Burkholz Figure 1A)] and a catheter extending distally from the catheter adapter [the catheter 16 may be secured within and extend distally from the catheter adapter 20 (Burkholz ¶0043, Figure 1A)];
coupling a delivery device to the catheter adapter [the second lumen of the catheter adapter 20 may be coupled with the extension 10 via the extension tube 22 that may extend from the second port 26 of the catheter adapter 20 (Burkholz ¶0045); the extension 10 may include a barrel or housing 28 (Burkholz ¶0048)], wherein the delivery device comprises a housing [housing 28 (Burkholz Figure 1A)] and a tubular instrument [instrument 12 (Figures 1A-C), wherein as depicted in Figures 1A-C, the instrument 12 is considered to be tubular], wherein the tubular instrument comprises a distal end [distal portion 41 (Burkholz Figure 1C)], a proximal end [proximal portion 43 (Burkholz Figure 1C)], and a lumen extending between the distal end and the proximal end [the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055, Figure 1B-C); the instrument 12 may then be advanced through the fluid pathway of the catheter assembly 14 and/or the distal tip 42 of the instrument may be placed into the vasculature distal to the tip 18 of the catheter 16. In some embodiments, following the advancement of the instrument, the syringe 54, which may be pre-filled, may be used to flush the catheter assembly 14 to remove stagnant blood and/or medication. In some embodiments, a plunger of the syringe 54 may be pulled to withdraw a discard sample. In some embodiments, the blood collection tube 48 may be coupled with the adapter 36 to obtain a blood sample (Burkholz ¶0068), wherein holes configured to allow for fluid flow into or out of the instrument 12, wherein the fluid is collected into a blood collection tube 48 connected to the instrument 12 or flushed through the instrument 12 from a syringe, is considered to define the claimed lumen], wherein the distal end comprises a distal-most distal tip forming a distal end of the lumen [distal tip 42 (Burkholz Figures 1B-C)], wherein the proximal end is secured within the housing [see proximal end 43 in Burkholz Figure 1C], wherein the tubular instrument is disposed within the housing and configured to advance distally with respect to the housing [the extension 10 or introducer may be configured to introduce the instrument 12 into a catheter assembly 14. In some embodiments, when the instrument 12 is introduced into the catheter assembly 14, the instrument 12 may access a fluid pathway of the catheter assembly 14 and/or the instrument may extend through the catheter assembly 14 and access vasculature of a patient (Burkholz ¶0040, Figure 1A)];
advancing the delivery device through the catheter, comprising advancing the tubular instrument distally with respect to the housing [the instrument 12 may then be advanced through the fluid pathway of the catheter assembly 14 and/or the distal tip 42 of the instrument may be placed into the vasculature distal to the tip 18 of the catheter 16 (Burkholz ¶0068)]; and
after advancing the delivery device through the catheter, activating a blood collection container [the blood collection tube 48 may be coupled with the adapter 36 to obtain a blood sample (Burkholz ¶0068, Figure 2D), wherein as depicted in Figure 2D, the advancement tab 46 indicates that the instrument 12 has been advanced]; and
wherein the housing of the delivery device defines a slot extending longitudinally between a distal end of the housing and a proximal end of the housing [the housing 28 may include a slot 34, which may extend parallel to a longitudinal axis of the housing 28 (Burkholz ¶0051, Figure 1A)], wherein the blood collection device connects to the proximal end of the tubular instrument through the slot [the extension 10 may include an adapter 36, which may be coupled to a proximal end of the instrument 12 (Burkholz ¶0053, Figures 1-2); the adapter 36 may include a cavity configured to receive, for example, a syringe and/or blood collection tube (Burkholz ¶0054, Figure 2D)], and wherein advancing the tubular instrument distally with respect to the housing includes advancing the blood collection device with respect to the housing in unison with the tubular instrument [the adapter 36 may be configured to move along the slot 34 from a proximal position to a distal position and/or from the distal position to the proximal position. In some embodiments, in response to movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28 (Burkholz ¶0053, Figures 1A-C)].
However, Burkholz fails to explicitly disclose wherein the delivery device a pressure-sensitive valve comprising a cross-slit disposed within a distal-most tip of the distal end, wherein the pressure-sensitive valve is configured to move from a closed state to an open state in response to a predetermined negative pressure differential within the lumen, wherein when the slit is in the closed state fluid is prevented from flowing through the lumen; and wherein in response to activating the blood collection device, the predetermined negative pressure differential within the lumen is created and the pressure-sensitive valve moves from the closed state to the open state.
Chevillon discloses a tubular instrument comprising a pressure-sensitive valve comprising a cross slit disposed within a distal-most tip of a distal end of a lumen of the tubular instrument [the valve could also consist of a slot extending essentially transverse to the axis of the conduit of the catheter tube. This slot can in particular have the form of a "linear" line. But we could also consider a curve conformation, or even other. Instead of a single slot, it has also been imagined the possibility of conforming the valve like a cross or even a star with at least three branches (Chevillon p. 3, Figures 6-7); in the version of FIGS. 6 and 7, or the front valve, identified here 11 ′, has the shape of a star with four branches (or cross), this shape having been obtained by simple cutting, along two perpendicular axes 10a, 10'a, of the rounded end wall 13 of the tube 10 (Chevillon p. 5, Figures 6-7)], wherein the pressure-sensitive valve is configured to move from a closed state to an open state in response to a predetermined negative pressure differential within the lumen [While at its proximal end the tube is open on the diameter of its internal conduit, its opposite end 1b is normally closed, while nevertheless having, substantially in the axis 10a, a two-way valve 5, arranged through the thickness of the front end wall lc of the tube to communicate on one side with the outside and on the other with the conduit 3, so that, when a predetermined pressure differential exists between the inside and Outside the tube, the valve can open, thereby defining a temporary liquid inlet or outlet port (Chevillon p. 4)], wherein when the slit is in the closed state fluid is prevented from flowing through the lumen [in the absence of vacuum inside the duct 3, controlled, for example, by a puncture, the front valve 5 will remain closed, thus preventing in particular that blood can unexpectedly penetrate inside the tube, then risking coagulation if no anti-coagulant product, such as "Heparin" is used, this possible coagulation of the blood requiring, in any case, a cleaning of the catheter after each use (Chevillon p. 4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz to employ a pressure-sensitive valve comprising a cross-slit disposed within a distal-most tip of the distal end, wherein the pressure-sensitive valve is configured to move from a closed state to an open state in response to a predetermined negative pressure differential within the lumen, wherein when the slit is in the closed state fluid is prevented from flowing through the lumen, so as to prevent local weakening of the wall of the tubular instrument [this frontal or facial arrangement of the valve must reduce the risk of local weakening of the wall of the catheter tube (Chevillon p. 2)] and allow for controlled fluid inflow into the lumen [Chevillon p. 4].
It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz in view of Chevillon to employ the predetermined negative pressure differential within the lumen is created and the pressure-sensitive valve moves from the closed state to the open state in response to activating the blood collection device, as this would amount to merely applying a known technique [pressure-sensitive valve responsive to a negative pressure applied to one side of the pressure-sensitive valve (Chevillon p. 4)] to a known device (method, or product) ready for improvement [evacuated container being activated (negative pressure of evacuated container being coupled to lumen of instrument 12) (Burkholz ¶0054)] to yield predictable results [pressure differential within lumen activating the pressure-sensitive valve] [MPEP § 2143(I)(D)].
However, while Burkholz discloses that the distal tip may be constructed of a softer and/or less rigid material than the proximal end of the tubular instrument [the distal tip 42 may be constructed of a softer and/or less rigid material than the proximal end of the instrument 12 for buckling resistance (Burkholz ¶0055)], as well as the tubular instrument having variable stiffness along the length of the tubular instrument [Additionally or alternatively, the instrument 12 may have variable stiffness along a length of the instrument 12 (Burkholz ¶0056)], Burkholz in view of Chevillon fails to explicitly disclose wherein the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen and proximal to the slit.
Engel discloses a tubular instrument, wherein Engel discloses that the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen [apertures 22 are disposed such that the major axis 38 is at a right angle to the longitudinal axis 28 of lumen 18… apertures 22 may be oriented such that major axis 38 is perpendicular to longitudinal axis 28 at locations where the cannula 10 exhibits the greatest degree of bending during use in surgery, and therefore presents the greatest need for buckle-resistant apertures (Engel ¶0028, Figures 3-4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz in view of Chevillon to employ a plurality of holes within the distal end in fluid communication with the lumen and proximal to the pressure-sensitive valve, in order to allow for increased flexibility of the tubular instrument while preventing buckling [Engel ¶0028, Figure 1].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Chevillon and Engel, as applied to claim 1 above, and in further view of Nordgren (US-20050043703-A1, previously presented).
Regarding claim 6, Burkholz in view of Chevillon and Engel teaches
The delivery system of claim 1.
However, Burkholz in view of Chevillon and Engel fails to explicitly disclose wherein a length of the cross slit extends across an entirety of a width of the distal end.
Nordgren discloses a tubular instrument comprising a pressure-sensitive valve comprising a slit at a distal-most distal end of the tubular instrument [The slit valves in the distal tips of catheter tubes comprise one or more slit valves, which may be either one-way or two-way valves... By one-way, it is meant a slit valve located in the distal tip of a catheter tube which either aspirates or infuses, but does not do both (Nordgren ¶0043); Accordingly, the tip at the distal end of a catheter tube may comprise from one slit valve up to several slit valves to both aspirate and infuse. One or more slit valves may be located at the tip in a rounded portion thereof or in a flat region, as deemed appropriate by those having skill in the art (Nordgren ¶0044)], wherein Nordgren discloses that the length of a pressure-sensitive valve is a result effective variable [It is not necessary that all slit valves comprise a slit having the same length. Some may intersect the apex of the distal tip, where the distal tip is selected to have an apex. The slits in any of the slit valves, may have a uniform thickness or a thickness which varies, as deemed most appropriate for an intended purpose (Nordgren ¶0044); Where it is desired to have a slit longer than the diameter of the catheter tube, the distal tip may be blunt and diagonally disposed with the slit running the full dimension of the tip or nearly so (Nordgren ¶0047); FIG. 6 illustrates a distal tip, generally designated 82, in the form of a duck-bill configuration comprising upper and lower exterior surfaces 84 and 86 (Nordgren ¶0055, Figure 6)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz in view of Chevillon and Engel to employ a cross slit having a length that extends across an entirety of a width of the distal end as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 22 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The Applicant further fails to place any criticality on the length of the claimed slit [In some embodiments, a length of the cross slit may extend across an entirety of a width of the distal end 22. In some embodiments, a length of the cross slit may extend only partially across a width of the distal end 22 (Applicant’s Specification ¶0051)].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Nordgren and Engel.
Regarding claim 8, Burkholz teaches
A delivery system comprising:
a delivery device comprising a housing [housing 28 (Burkholz Figure 1A)] and configured to couple to a catheter adapter [catheter adapter 20 (Burkholz Figure 1A)] at a proximal end of the catheter adapter [the second lumen of the catheter adapter 20 may be coupled with the extension 10 via the extension tube 22 that may extend from the second port 26 of the catheter adapter 20 (Burkholz ¶0045); the extension 10 may include a barrel or housing 28 (Burkholz ¶0048)], the catheter adapter configured to couple to a catheter at a distal end of the catheter adapter [the catheter 16 may be secured within and extend distally from the catheter adapter 20 (Burkholz ¶0043, Figure 1A)], and a tubular instrument [instrument 12 (Figures 1A-C), wherein as depicted in Figures 1A-C, the instrument 12 is considered to be tubular] configured to be inserted through the housing of the delivery device, the catheter adapter, and the catheter [Burkholz Figures 1A-C];
the tubular instrument comprising a distal end [distal portion 41 (Burkholz Figure 1C)], a proximal end [proximal portion 43 (Burkholz Figure 1C)], and a lumen extending between the distal end and the proximal end [the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055, Figure 1B-C); the instrument 12 may then be advanced through the fluid pathway of the catheter assembly 14 and/or the distal tip 42 of the instrument may be placed into the vasculature distal to the tip 18 of the catheter 16. In some embodiments, following the advancement of the instrument, the syringe 54, which may be pre-filled, may be used to flush the catheter assembly 14 to remove stagnant blood and/or medication. In some embodiments, a plunger of the syringe 54 may be pulled to withdraw a discard sample. In some embodiments, the blood collection tube 48 may be coupled with the adapter 36 to obtain a blood sample (Burkholz ¶0068), wherein holes configured to allow for fluid flow into or out of the instrument 12, wherein the fluid is collected into a blood collection tube 48 connected to the instrument 12 or flushed through the instrument 12 from a syringe, is considered to define the claimed lumen], wherein the distal end comprises a distal-most distal tip forming a distal end of the lumen [distal tip 42 (Burkholz Figures 1B-C)], wherein the tubular instrument is configured to advance distally with respect to the housing [the extension 10 or introducer may be configured to introduce the instrument 12 into a catheter assembly 14. In some embodiments, when the instrument 12 is introduced into the catheter assembly 14, the instrument 12 may access a fluid pathway of the catheter assembly 14 and/or the instrument may extend through the catheter assembly 14 and access vasculature of a patient (Burkholz ¶0040, Figure 1A)];
a blood collection device [adapter 36 (Burkholz Figures 1-2)] in fluid communication with the lumen of the tubular instrument [the extension 10 may include an adapter 36, which may be coupled to a proximal end of the instrument 12 (Burkholz ¶0053, Figures 1-2); the adapter 36 may include a cavity configured to receive, for example, a syringe and/or blood collection tube (Burkholz ¶0054, Figure 2D)], wherein the housing of the delivery device defines a slot extending longitudinally between a distal end of the housing and a proximal end of the housing [the housing 28 may include a slot 34, which may extend parallel to a longitudinal axis of the housing 28 (Burkholz ¶0051, Figure 1A)], wherein the blood collection device connects to the proximal end of the tubular instrument through the slot [Burkholz Figures 1A-C], and wherein the blood collection device is configured to advance distally with respect to the housing in unison with the tubular instrument [the adapter 36 may be configured to move along the slot 34 from a proximal position to a distal position and/or from the distal position to the proximal position. In some embodiments, in response to movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28 (Burkholz ¶0053, Figures 1A-C)].
However, while Burkholz discloses wherein the tubular instrument comprises inlet and/or outlet holes at the distal tip [the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055, Figure 1B-C)], Burkholz fails to explicitly disclose a linear slit within the distal tip, wherein the linear slit is configured to move from a closed position to an open position in response to a predetermined negative pressure differential within the lumen, wherein the linear slit is configured to close in response to a pressure differential within the lumen above the predetermined negative pressure differential within the lumen.
Nordgren disclose a tubular instrument, wherein the tubular instrument comprises a linear slit [The slit valves in the distal tips of catheter tubes comprise one or more slit valves, which may be either one-way or two-way valves... By one-way, it is meant a slit valve located in the distal tip of a catheter tube which either aspirates or infuses, but does not do both (Nordgren ¶0043); Accordingly, the tip at the distal end of a catheter tube may comprise from one slit valve up to several slit valves to both aspirate and infuse. One or more slit valves may be located at the tip in a rounded portion thereof or in a flat region, as deemed appropriate by those having skill in the art (Nordgren ¶0044); see also Figures 6 and 12 of Nordgren] within a distal-most distal tip of the tubular instrument [Nordgren ¶¶0043-0044, see also Figures 6 and 12 of Nordgren], wherein the linear slit is configured to move from a closed position to an open position in response to a negative pressure differential within the lumen, wherein the linear slit is configured to close in response to a pressure differential within the lumen above the predetermined negative pressure differential within the lumen [The material at each slit valve must have sufficient flexibility for the lips forming the slit to flex inwardly or outwardly or both when predetermined pressure differentials are imposed thereon, in order to accommodate fluid flow in the direction desired (Nordgren ¶0045); The slit 102 remains closed unless and until a pressure differential exists of selected magnitude between the interior pressure and exterior pressure of the tip such that the lips of the valve 103 are flexed outwardly to open the slit 102 to accommodate infusion, as illustrated in FIG. 10 or inwardly, as illustrated in FIG. 11, to accommodate aspiration (Nordgren ¶0060)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz to employ a linear slit within the distal tip, wherein the linear slit is configured to move from a closed position to an open position in response to a predetermined negative pressure differential within the lumen, wherein the linear slit is configured to close in response to a pressure differential within the lumen above the predetermined negative pressure differential within the lumen, so as to allow for controlled fluid inflow into the lumen [Nordgren ¶¶0045, 0060].
However, while Burkholz discloses that the distal tip may be constructed of a softer and/or less rigid material than the proximal end of the tubular instrument [the distal tip 42 may be constructed of a softer and/or less rigid material than the proximal end of the instrument 12 for buckling resistance (Burkholz ¶0055)], as well as the tubular instrument having variable stiffness along the length of the tubular instrument [Additionally or alternatively, the instrument 12 may have variable stiffness along a length of the instrument 12 (Burkholz ¶0056)], Burkholz in view of Nordgren fails to explicitly disclose wherein the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen and proximal to the pressure-sensitive valve.
Engel discloses a tubular instrument, wherein Engel discloses that the tubular instrument comprises a plurality of holes within the distal end in fluid communication with the lumen [apertures 22 are disposed such that the major axis 38 is at a right angle to the longitudinal axis 28 of lumen 18… apertures 22 may be oriented such that major axis 38 is perpendicular to longitudinal axis 28 at locations where the cannula 10 exhibits the greatest degree of bending during use in surgery, and therefore presents the greatest need for buckle-resistant apertures (Engel ¶0028, Figures 3-4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery system of Burkholz in view of Nordgren to employ a plurality of holes within the distal end in fluid communication with the lumen and proximal to the pressure-sensitive valve, in order to allow for increased flexibility of the tubular instrument while preventing buckling [Engel ¶0028, Figure 1].
Regarding claim 9, Burkholz in view of Nordgren and Engel teaches
The delivery system of claim 8, wherein the linear slit is oriented parallel to a longitudinal axis of the tubular instrument [See Nordgren Figure 6, wherein the duckbill valve as formed by surfaces 84 and 86 is considered to extend such that the linear slit is oriented parallel to a longitudinal axis of the tubular instrument of Nordgren].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Nordgren and Engel, as applied to claim 8 above, and in further view of Groshong (US-4549879-A, previously presented).
Regarding claim 10, Burkholz in view of Nordgren and Engel teaches
The delivery system of claim 8.
However, Burkholz is not particular regarding the material of the tubular instrument [Burkholz ¶0055], such that Burkholz fails to explicitly disclose wherein the distal end of the tubular instrument is constructed of silicon.
Groshong discloses delivery systems comprising tubular instruments comprising a pressure-sensitive slit valve, wherein Groshong discloses that the distal end of the tubular instrument is constructed of silicon [The valve 10 is typically disposed in a catheter 12 fabricated of a durable, flexible, biocompatible material such as silicon rubber (Groshong, Col 5, lines 46-49)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery system of Burkholz in view of Nordgren and Engel to employ the distal end of the tubular instrument being constructed of silicon, as this modification would amount to mere simple substitution of one known element [soft material (Burkholz ¶0055)] for another [silicon rubber of Groshong] to obtain predictable results [allow for flexibility of the tubular instrument] [MPEP § 2143(I)(B)].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Nordgren and Engel, as applied to claim 8 above, and in further view of Schon (US-5578006-A, previously presented).
Regarding claim 11, Burkholz in view of Nordgren and Engel teaches
The delivery system of claim 8.
However, Burkholz is not particular regarding the material of the tubular instrument [Burkholz ¶0055], such that Burkholz fails to explicitly disclose wherein the distal end of the tubular instrument is constructed of polypropylene.
Schon discloses a catheter constructed of polypropylene [catheter tube is made of a nontoxic, flexible, bendable material such as natural or synthetic rubber, polypropylene, polyethylene, polyvinyl chloride, or polyamides (Col 3, lines 43-46)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Burkholz in view of Nordgren and Engel to employ the distal end of the tubular instrument being constructed of polypropylene, as this modification would amount to mere simple substitution of one known element [soft material (Burkholz ¶0055)] for another [polypropylene of Schon] to obtain predictable results [allow for flexibility of the tubular instrument] [MPEP § 2143(I)(B)].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Chevillon and Engel, as applied to claim 12 above, and in further view of Groshong.
Regarding claim 17, Burkholz in view of Chevillon and Engel teaches
The method of claim 12.
However, Burkholz is not particular regarding the material of the tubular instrument [Burkholz ¶0055], such that Burkholz fails to explicitly disclose wherein the distal end of the tubular instrument is constructed of silicon.
Groshong discloses delivery systems comprising tubular instruments comprising a pressure-sensitive slit valve, wherein Groshong discloses that the distal end of the tubular instrument is constructed of silicon [The valve 10 is typically disposed in a catheter 12 fabricated of a durable, flexible, biocompatible material such as silicon rubber (Groshong, Col 5, lines 46-49)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz in view of Chevillon and Engel to employ the distal end of the tubular instrument being constructed of silicon, as this modification would amount to mere simple substitution of one known element [soft material (Burkholz ¶0055)] for another [silicon rubber of Groshong] to obtain predictable results [allow for flexibility of the tubular instrument] [MPEP § 2143(I)(B)].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Chevillon and Engel, as applied to claim 12 above, and in further view of Schon.
Regarding claim 18, Burkholz in view of Chevillon and Engel teaches
The method of claim 12.
However, Burkholz is not particular regarding the material of the tubular instrument [Burkholz ¶0055], such that Burkholz fails to explicitly disclose wherein the distal end of the tubular instrument is constructed of polypropylene.
Schon discloses a catheter constructed of polypropylene [catheter tube is made of a nontoxic, flexible, bendable material such as natural or synthetic rubber, polypropylene, polyethylene, polyvinyl chloride, or polyamides (Col 3, lines 43-46)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular instrument of Burkholz in view of Chevillon and Engel to employ the distal end of the tubular instrument being constructed of polypropylene, as this modification would amount to mere simple substitution of one known element [soft material (Burkholz ¶0055)] for another [polypropylene of Schon] to obtain predictable results [allow for flexibility of the tubular instrument] [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 8 May 2025, with respect to the rejection(s) of claims 1, 3, 12, and those dependent therefrom under § 112(a) have been fully considered and are persuasive. The rejections of claims 1, 3, 12, and those dependent therefrom under § 112(a) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 1, 8, 12, and those dependent therefrom under Nordgren in view of Heck, Samson, and Engel with respect to claim 1, Nordgren in view of Heck and Engel with respect to claim 8, and Nordgren in view of Heck, Samson, Engel, and Groshong with respect to claim 12 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 Burkholz in view of Chevillon and Engel with respect to claims 1 and 12, and Burkholz in view of Nordgren and Engel with respect to claim 8.
Regarding claim 1, the Applicant asserts that the amended subject matter of “a blood collection device in fluid communication with the lumen of the tubular instrument, wherein the housing of the delivery device defines a slot extending longitudinally between a distal end of the housing and a proximal end of the housing, wherein the blood collection device connects to the proximal end of the tubular instrument through the slot, and wherein the blood collection device is configured to advance distally with respect to the housing in unison with the tubular instrument” is not disclosed or suggested by the art or record applied under § 103 [similar arguments are made with respect to claims 8 and 12]. However, the Examiner notes that the Applicant’s arguments with respect to claims 1, 8, 12, and those dependent therefrom have been fully 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. A new grounds of rejection is made in view of Burkholz in view of Chevillon and Engel with respect to claims 1 and 12, and Burkholz in view of Nordgren and Engel with respect to claim 8, wherein Burkholz is considered to disclose the argued subject matter of a blood collection device [adapter 36 (Burkholz Figures 1-2)] in fluid communication with the lumen of the tubular instrument [Burkholz ¶0053, Figures 1-2; Burkholz ¶0054, Figure 2D], wherein the housing of the delivery device defines a slot extending longitudinally between a distal end of the housing and a proximal end of the housing [Burkholz ¶0051, Figure 1A], wherein the blood collection device connects to the proximal end of the tubular instrument through the slot [Burkholz Figures 1A-C], and wherein the blood collection device is configured to advance distally with respect to the housing in unison with the tubular instrument [Burkholz ¶0053, Figures 1A-C].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sakai (US-8114047-B2) discloses a tubular instrument with a pressure-sensitive valve comprising a cross slit disposed at a distal-most portion of a distal tip and at a distal end of a lumen of the tubular instrument [In addition, hole or incision (in other words, slit or cut) as shown in FIG. 4 is defined in the distal end wall 21 of the catheter main body 20 (Sakai Col 5:10-12, Figure 4D)], wherein the pressure-sensitive valve is configured to move from a closed position to an open position in response to a positive pressure differential within the lumen being within a predetermined pressure window [In this manner, since the hole 21a and the incisions 21b, 21c, 21d are defined in the distal end wall 21, when the drug solution is infused into the catheter 10, the hole 21a or the incision 21b, 21c, or 21d defined in the distal end wall 21 resiliently open by the pressure of the drug solution, so that infusion of the drug solution is achieved. Then, after having completed the infusion of the drug solution, the distal end wall 21 is resiliently restored and closed, so that inflow of blood can be effectively prevented (Sakai Col 5:37-45)]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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