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 .
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.
Claims 1-4, 8-12, 16-17, 21-29, 31-32 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 1 recites the limitation "may be” in line 15. It is unclear if the limitation after the term may be is positively recited or not. For the purpose of examination, the examiner will interpret the limitation as it is not positively recited.
Claim 1 recites the limitation "the distal most portion" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "an outer wall of the access needle" in line 17. It is unclear if it is referring to the limitation in line 12 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in line 12.
Claim 2 recites the limitation " wherein when the slide in a distal most position a distal portion of the guide element " in lines 1-2. It is unclear limitation if it means “wherein when the slide in a distal most position,
Claim 3 recites the limitation " wherein when the slide in a distal most position a distal portion of the guide element " in lines 1-2. It is unclear limitation if it means “wherein when the slide in a distal most position,
Claim 9 recites the limitation "a proximal end of the access needle" in line 2. It is unclear if it is referring to the limitation in lines 9-10 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in lines 9-10 of claim 1.
Claim 9 recites the limitation "a housing" in lines 1-2. It is unclear if it is referring to a handle as in claim 1, line 2 (see specification in ¶0034, wherein the handle is the same as housing” or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to it is referring a handle as in claim 1, line 2.
Claim 10 recites the limitation "a distal end of the housing" in lines 1-2. It is unclear if it is referring limitation in lines 2-3 of claim 1 (see specification in ¶0034, wherein the handle is the same as housing” or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to it is referring to the limitation in lines 2-3 of claim 1.
Claim 10 recites the limitation "may be” in last line. It is unclear if the limitation after the term may be is positively recited or not. For the purpose of examination, the examiner will interpret the limitation as it is not positively recited.
Claim 28 recites the limitation "a length greater than a width and a width that is greater than a thickness” in lines 2-3. It is unclear if the limitation if there are many width or just one width . For the purpose of examination, the examiner will interpret the limitation as “a length greater than a width and the width
Claim 29, “the guide element is made entirely or partially of a polymeric material, a PTFE, a Nylon or wherein the guide element is made entirely or partially of metal, comprising Nitinol, comprising Elgiloy or similar materials” in lines 2-4. It is unclear if it means “the guide element is made entirely or partially of a polymeric material, a PTFE, a Nylon or a metal, and wherein the metal is comprising Nitinol, : a polymeric material, a PTFE, a Nylon , a metal comprising Nitinol, : a polymeric material, a PTFE, a Nylon , a metal comprising Nitinol, Elgiloy or similar materials”.
Claim 31 recites the limitation "an outer wall of the access needle" in last two lines. It is unclear if it is referring to the limitation in line 12 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in line 12.
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.
Claim(s) 1-4. 8-12, 16-17, 21, 25-27, 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking et al. (US. 5704914)(“ Stocking”) in view of Murphy (US. 20200254214A1).
Re claim 1, Stocking discloses an intravascular catheter assembly (Fig. 1-12, abstract, Col. 4, lines 1-11), comprising: a handle (Figs. 1-2) having a proximal end ( close to 22) and a distal end ( close to 18), a slot (42) in a surface of the handle having a distal end and a proximal end (Fig. 1); an actuation button (48) on the handle coupled to a needle carrier (37); a tubular catheter body (12, 14) having a distal end ( top end of 27, Fig. 1), a proximal end( lower end of 12), and a lumen extending between the proximal end and the distal end (lumen for the needle 27), the proximal end of the catheter body coupled to the distal end of the handle (Fig. 1, by the catheter hub 14); an access needle (27) disposed in the tubular catheter body lumen (Fig. 1) having a tissue-penetrating distal tip( dip end 28 of the needle) extending distally beyond the distal end of the tubular catheter body (Fig. 41) and a proximal end coupled to the needle carrier ( lower end coupled to 37); a guide element (32) having a proximal end ( lower end of 42, Fig. 1) and a distal end ( top end of 32), the guide element positioned within the catheter body lumen (Fig. 1), wherein the access needle and the guide element may be withdrawn together from the tubular catheter body after the distal most portion of the guide element has been advanced from the tubular catheter body lumen along an outer wall of the access needle to a position distal to the tissue-penetrating distal tip of the access needle (32 and the needle can be retracted together , Fig. 4); and a slide (46, 44) coupled to the proximal end of the guide element (Fig. 2, Col. 4, line 66 up to Col. 5, lines 10) so that distal advancement of the slide advances the distal tip end portion of the guide element (Fig. 2, Col. 4, line 66 up to Col. 5, lines 1) from a position long the outer wall of the access needle (Fig. 3), but it fails to discloses a guide element cutout in the distal end, and the guide element positioned adjacent to an outer wall of the access needle, a distal end portion of the guide element is shaped to provide a uniform transition when the distal end portion is within the guide element cutout, the guide element position is within the guide element cutout distally.
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout ( opening at 19) in the distal end (19), and the guide element positioned adjacent to an outer wall of the access needle (12, Fig. 3), a distal end portion of the guide element is shaped to provide a uniform transition when the distal end portion is within the guide element cutout ( tip of 13), the guide element position is within the guide element cutout distally (Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter and the guide element of Stocking to include a guide element cutout in the distal end of the catheter so that the guide element positioned adjacent to an outer wall of the access needle, a distal end portion of the guide element is shaped to provide a uniform transition when the distal end portion is within the guide element cutout, the guide element position is within the guide element cutout distally as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 2, Stocking discloses wherein when the slide is in a distal most position (Fig. 3), fails to disclose a distal portion of the guide element curves beyond the tissue penetrating distal tip of the access needle.
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout in the distal end (19), and wherein when the slide is in a distal most position a distal portion of the guide element curves beyond the tissue penetrating distal tip of the access needle (Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the guide element of Stocking so that when the slide is in a distal most position a distal portion of the guide element curves beyond the tissue penetrating distal tip of the access needle as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 3, Stocking discloses wherein when the slide is in a distal most position (Fig. 3), fails to disclose a distal portion of the guide element curves from a position above the access needle, beyond the tissue penetrating distal tip of the access needle to a position below the access needle.
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout in the distal end (19), and wherein when the slide is in a distal most position a distal portion of the guide element curves from a position above the access needle ( as 13 is inside 101 to a location above 17), beyond the tissue penetrating distal tip of the access needle to a position below the access needle ( Fig. 3, as 13 has to below 17).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the guide element of Stocking so that when the slide is in a distal portion of the guide element curves from a position above the access needle, beyond the tissue penetrating distal tip of the access needle to a position below the access needle as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 4, Stocking fails to disclose wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 360 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 180 degrees.
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout in the distal end (19), and the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 360 degrees (Fig. 3, rotation is less than 360 degree), or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 180 degrees
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the guide element of Stocking so that the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 360 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is less than 270 degrees, or wherein the angle of the curve formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle is more than 180 degrees as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 8, Stocking discloses wherein the slide is disposed over a proximal region of the access needle (Fig. 3).
Re claim 9, Stocking discloses a housing ( see 112 b rejection, 20 in Fig. 3) attached to a proximal end of the access needle (Fig. 1), wherein the slide is disposed over the housing (46, 44, Fig. 2).
Re claim 10, Stocking discloses wherein the access needle is fixedly secured to a distal end of the housing (37, Fig. 2) and the tubular catheter body is detachably secured to the distal end of the housing ( threaded at 16, Fig. 3 can be detached), wherein the slide advances the guide element beyond the distal end of the catheter (Fig. 3) and wherein the housing, access needle and guide element may be detached and removed from the catheter after the catheter is in place * can be due to the threaded area 16, Fig. 3).
Re claim 11, Stocking discloses wherein a proximal region of the catheter is disposed within the housing (lower portion of the catheter hub 14in within the housing 18, Fig. 3) and wherein the proximal end of the catheter and the proximal end of the access needle are configured to be engaged by the slide to advance the catheter and needle in tandem with the guide element relative to the housing after the guide element has been extended distally beyond the distal end of the catheter (Fig. 3).
Re claim 12, Stocking discloses wherein the access needle has a lumen ( lumen of the needle 27), but it fails to disclose that the guide element is disposed outside of the access needle lumen
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout in the distal end (19), and the guide element is disposed outside of the access needle lumen (Fig. 2).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter and the guide element of Stocking so that the guide element is disposed outside of the access needle lumen as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 16, Stocking discloses wherein the guide element is slidably disposed within a guide structure within the catheter body lumen (inner portion of 56. Fig. 3).
Re claim 17, Stocking discloses wherein the guide structure maintains the guide element in a position along an upper most portion of the access needle ( it is capable to keep the position as in Fig. 3).
Re claim 21, Stocking fails to disclose wherein the guide structure has a distal most portion adjacent to the guide element cutout and a proximal portion wherein the guide structure is continuous along the interior wall of the catheter body lumen from the proximal end to the distal end.
However, Murphy discloses an intravascular catheter assembly (Fig. 1-5, abstract, ¶0024), comprising: a catheter ( 101), a needle 12) and a guide element (13) and wherein the catheter has a guide element cutout in the distal end (19), and wherein the guide structure (20) has a distal most portion adjacent to the guide element cutout (portion near 19) and a proximal portion wherein the guide structure is continuous along the interior wall of the catheter body lumen from the proximal end to the distal end (portion of 20 near 11, Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter and the guide element of Stocking so that the guide structure has a distal most portion adjacent to the guide element cutout and a proximal portion wherein the guide structure is continuous along the interior wall of the catheter body lumen from the proximal end to the distal end as taught by Murphy for the purpose of placing the catheter in a transvers veins (Murphy, ¶0033).
Re claim 25, the modified Stocking discloses further comprising: a first configuration (Stocking, 44 is slide to lower point, Fig. 4) when the slide is in a proximal most position wherein the distal end of the guide element is in the guide element cutout and the tissue penetrating distal tip of the needle is distal to the distal most end of the tubular catheter body (Stocking, Fig. 4, wherein only 44 is slide, but 37 still on distal position ); a second configuration (Fig. 2, Stocking) when the slide is in a distal most position wherein the distal most end of the guide element is beyond the guide cutout and curved beyond the tissue penetrating distal tip of the needle (Stocking, Fig. 2); and a third configuration when the slide is in a position proximal to the distal most position and the needle and the guide element are at least partially retracted into the housing ( Stocking, when the slide 44 is between position in Fig, 2 and Fig. 3).
Re claim 26, Stocking discloses wherein in the first configuration the distal tip of the access needle extends beyond the distal end of the tubular catheter body by a distance (Fig. 3 of Stocking ), and a proximal end of the slide is retracted from the proximal end of the tubular catheter body by a distance (Fig. 3 of Stocking ), but it is silent as to the specifics of the distance of the distal tip extending is in a range from 0.1 mm to 20 mm and the retracted distance of the slide is in a range from 10 mm to 100 mm.
The instant disclosure describes the parameter of the distances as being merely preferable, and does not describe the distances as contributing any unexpected results to the system. As such, parameters such as distances are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of extending distance of the distal tip of the guide element and the retracted distance of the slide would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 27, the modified Stocking discloses wherein in the second configuration the length of the guide element extending beyond the guide cut out of the tubular catheter body (Fig, 2 of Stocking), but it is silent as to the specifics of extending length of the guide element is from 5 mm to 100 mm. The instant disclosure describes the parameter of the extending length as being merely preferable, and does not describe the extending length as contributing any unexpected results to the system. As such, parameters such as the extending length are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the extending length of the guide element would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 31, the modified Stocking discloses the guide element further comprising an upper surface conforming to a curvature of an interior wall of the catheter body lumen ( Murphy, Fig. 4, the top surface of 11) and a lower surface conforming to a curvature of an outer wall of the access needle (Murphy, Fig. 4, the lower surface of 11 conforming the outer surface of the needle 10).
Re claim 32, the modified Stocking discloses wherein the catheter is configured for use as a catheter component of an infusion set, a catheter component in a blood collection set, a catheter component in a safety winged blood collection set, or a catheter component in an intravenous catheter ( blood collection , abstract, Col.8, lines 25-40).
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking in view of Murphy and further in view of Belson (US 20140180250 A1).
Re claim 22, Stocking fails to disclose wherein the tubular catheter body has a proximal hub with a hemostasis valve, wherein the access needle slidably extends through the hemostasis valve.
However, Belson discloses a catheter system (Fig. 1-7) and wherein the tubular catheter body (102) has a proximal hub (105) with a hemostasis valve (110, ¶0033), wherein the access needle (7) slidably extends through the hemostasis valve (¶0031, ¶0033).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the tubular catheter body of Stocking to include hemostasis valve so that the tubular catheter body has a proximal hub with a hemostasis valve, wherein the access needle slidably extends through the hemostasis valve as taught by Belson for the purpose of sealing around the needle and preventing fluid leaking (Belson, ¶0033).
Re claim 23, Stocking discloses wherein the slide has a distal face ( top end of 46, 44) which mates with a proximal face of the needle carrier (lower face of 37) when the slide is fully advanced distally to extend the guide element (Fig. 2).
Re claim 24, Stocking discloses wherein the slide detachably locks to the proximal end of the needle carrier when the distal face mates with the proximal face (Fig. 2).
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking in view of Murphy and further in view of Kurth et al. (US 20090105654 A1) (“Kurth”).
Re claim 28, Stocking discloses that wherein the guide element has a length greater than a width (length and width of 32, Fig. 1) and a width that is greater than a thickness.
However, Kurth discloses a catheter system (Fig. 1-3) and wherein the guide element (20, Fig. 3) has a length (length at the longitudinal axis, Fig. 3) is greater than the width (width of 26) and the width is greater than the thickness ( thickness of 26).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the guide element of Stocking that guide element has width that is greater than a thickness as taught by Kurth for the purpose of increasing the flexibility and curvature in desired direction so it bends to desired direction (Kurth, ¶0054).
Re claim 29, Stocking fails to disclose wherein the guide element is made entirely or partially of a polymeric material, a PTFE, a Nylon or wherein the guide element is made entirely or partially of metal, comprising Nitinol, comprising Elgiloy or similar materials.
However, Kurth discloses a catheter system (Fig. 1-3) and wherein the guide element (20, Fig. 3) is made entirely or partially of a polymeric material, a PTFE, a Nylon or wherein the guide element is made entirely or partially of metal, comprising Nitinol, comprising Elgiloy or similar materials (¶0060, metal of PTFE, Nitinol).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the guide element of Stocking that the guide element is made entirely or partially of a polymeric material, a PTFE, a Nylon or wherein the guide element is made entirely or partially of metal, comprising Nitinol, comprising Elgiloy or similar materials as taught by Kurth for the purpose of using a flexible material to increase the flexibility and curvature in desired direction so it bends to desired direction (Kurth, ¶0054, ¶0060).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783