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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 4th 2025 has been entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehrenreich (US 20180272107 A1).
Regarding claims 1-2, Ehrenreich discloses a vascular access device (abstract, [0002]; transfer device 200, [0079] & Fig. 3-5), comprising: a housing (introducer 210, [0079] & Fig. 3-7), comprising a proximal end, a distal end, and a slot (introducer 210 comprising a proximal end portion 221/231, a distal end portion 222/232, and a first portion 214, which is being interpreted as a slot, [0080]-[0081] and [0091] & Fig. 5-12), wherein an inner surface of the housing (all inner surfaces of introducer 210, including inner surface 223/233, are being interpreted as an inner surface of introducer 210, [0086] & Fig. 6-7 and 12) comprises
a groove, wherein the groove is linear, disposed within the housing between the proximal end of the housing and the distal end of the housing (second portion 215, which is a long, narrow, linear channel, or a groove, is disposed in introducer 210 between portion 221/231 and portion 222/232, [0091] & see Fig. 6-7, 11-12, and 22), wherein the groove is a depression in the inner surface of the housing (second portion 215 may be interpreted as a part that is lower than the surrounding area, a hollow part of introducer 210, or a depression, in the inner surface of introducer 210, see Fig. 6-7 and 12);
an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position (actuator 270 extends through first portion 214 and is configured to advance along the outer surface 235 of introducer 210 along first portion 214 between a retracted position (Fig. 21-22) and an advanced position (Fig. 27-28), [0081]-[0082], [0093], [0108], [0116], and [0121] & Fig. 19-20);
an instrument disposed within the groove, the instrument comprising a first end and a second end (catheter 260 disposed in second portion 215, [0093] & Fig. 22; “…the catheter 260 has a proximal end portion 261 and a distal end portion 262…”, [0102] & Fig. 16),
wherein in response to movement of the advancement element from the retracted position to the advanced position, the second end of the instrument is advanced beyond the distal end of the housing (“…the catheter 260 can be in the second position when the actuator 270 is in a distal most position.”, [0121] & Fig. 25-29; see [0118]); and
a support feature disposed on top of the groove or within the groove (“Although not shown in in the transfer devices 100, 200, 300, 400, 500, 600, 700, and/or 800, any of the fluid transfer device described herein can include an internal support member configured to guide, shield, protect, and/or otherwise support, for example, the catheter disposed within the introducer.”, [0161]; internal support member 1086 is disposed within second portion 215/1015, as illustrated in Fig. 44, see [0166]; alternatively, member 1086 can be interpreted as disposed on top of second portion 215/1015 as second portion 215 is an open structure with a bottom on which member 1086 is placed on top of; the Examiner also notes that the limitation of “on top of” is relative and may depend on viewing perspective and that a top and bottom orientation has not been claimed) and configured to move distally in response to movement of the advancement element from the retracted position to the advanced position (“With the internal support member 1086 arranged and/or configured as a bellows, movement of the actuator 1070 results in a compression, deformation, and/or collapse of the internal support member 1086. That is to say, movement of the actuator 1070 from a proximal position toward a distal position compresses the bellows formed by and/or otherwise included in the internal support member 1086.”, [0166]-[0167] & Fig. 44),
wherein the support feature limits displacement of the instrument from the groove (“an internal support member configured to guide, shield, protect, and/or otherwise support, for example, the catheter disposed within the introducer.”, [0161] & Fig. 44; member 1086 limits the displacement of the catheter 260/1060 from second portion 215/1015), and further wherein the support feature is positioned distally from the advancement element such that no part of the advancement element extends distally past the support feature (“The internal support member 1086 is disposed in the inner volume 1013 between the second portion 1075 of the actuator 1070 and an interior distal surface of the introducer 1010”, [0167] & Fig. 44; member 1086 is positioned distally from second portion 275/1075 of actuator 270/1070 such that no part of actuator 270/1070 extends distally part member 1086, see Fig. 44).
Regarding claim 3, Ehrenreich discloses all the limitations of claim 1. Ehrenreich further discloses the vascular access device wherein the support feature is disposed on top of the groove (member 1086 can be interpreted as disposed on top of second portion 215/1015 as second portion 215 is an open structure with a bottom on which member 1086 is placed on top of; the Examiner also notes that the limitation of “on top of” is relative and may depend on viewing perspective and that a top and bottom orientation/surface has not been claimed), wherein in response to movement of the advancement element from the retracted position to the advanced position, the advancement element contacts a proximal end of the support feature and pushes the support feature distally along the groove (“With the internal support member 1086 arranged and/or configured as a bellows, movement of the actuator 1070 results in a compression, deformation, and/or collapse of the internal support member 1086. That is to say, movement of the actuator 1070 from a proximal position toward a distal position compresses the bellows formed by and/or otherwise included in the internal support member 1086.”, [0166]-[0167] & Fig. 44; actuator 270/1070 contacts a proximal end of member 1086 and pushes member 1086 distally along second portion 215/1015).
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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palushi (US 20200187967 A1), in view of Ha (US 20160287065 A1).
Regarding claim 1, Palushi discloses a vascular access device (instrument 210 is configured to enter anatomical passageways, [0061]), comprising: a housing (outer surface of assembly 220, Fig. 4 and 5), comprising a proximal end, a distal end, and a slot (outer surface of assembly 220 having a proximal and distal end and a slot in which slider 222 slides, see [0051] & Fig. 5 and 7A-7E), wherein an inner surface of the housing comprises a groove disposed within the housing between the proximal end of the housing and the distal end of the housing (the bottom half of the inside of assembly 220 is being interpreted as the groove, Fig. 5; the bottom of the groove is defined by the bottom surface of the inside of assembly 220, which is annotated in annotated Fig. 7A below as “Bottom Surface”); an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position (catheter slider 222 extending through the slot and configured to move linearly between a retracted position, position seen in Fig. 7A, and an advanced position, position seen in Fig. 7C, [0051]-[0052] and [0060]);
an instrument disposed within the groove (dilation catheter 270, which is being interpreted as the instrument, is disposed in the bottom half of assembly 220, [0047] & Fig. 5 and 7A), the instrument comprising a first end and a second end (catheter 270 has a second end 272 and a first end that extends through assembly 220, [0047] & Fig. 5 and 7A), wherein in response to movement of the advancement element from the retracted position (Fig. 7A) to the advanced position (Fig. 7C), the second end of the instrument is advanced beyond the distal end of the housing (see [0056] & Fig. 7A-7E and 8A-8E); and a support feature disposed on top of the groove or within the groove and configured to move distally in response to movement of the advancement element from the retracted position to the advanced position (extendable member slider 226, which is being interpreted as the support feature, is disposed on top of the bottom half of assembly 220 and configured to move distally in response to the distal advancement of slider 222, [0060] & Fig. 7B-7C), wherein the support feature limits displacement of the instrument from the groove (slider 226 limits the displacement of member 270 from the bottom half of assembly 220, [0060] & Fig. 7C and 8C; slider 226 must be displaced in order for member 270 to move further out of assembly 220, which is being interpreted as displacement of the instrument from the groove), and further wherein the support feature is positioned distally from the advancement element (slider 226 is positioned distally from catheter slider 222, see Figs. 7A-7C) such that no part of the advancement element extends distally past the support feature (no part of catheter slider 222 extends distally past slider 226, see Figs. 1A-1C and 7A-7E).
Palushi, as cited above, discloses an inner surface of the assembly 220 comprising a bottom surface defining the bottom-most portion of the bottom half of the inside of assembly 220 but fails to explicitly disclose wherein the groove is a depression in the inner surface of the housing.
However, Ha teaches a handle 650 comprising a slot (elongated opening 658, [0162] & Fig. 26), a groove (channel 656, [0162] & Fig. 26), wherein the groove is a depression in the inner surface of the housing (channel 656 is formed in body member 652 and may reasonably be interpreted as a place that is lower than the surrounding area, or a depression, in the inner surface of body member 652 considering channel 656 is an open part of member 652 configured to house part of actuator 660, [0162] and [0165] & Fig. 24 and 6), and an advancement element extending through the slot and configured to move linearly along the slot (actuator 660 extending through elongated opening 658 and configured to translate within channel 656, [0162] & Fig. 26).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the groove of Palushi with Ha to include the groove being a depression in the inner surface of the housing since such a modification would provide defined structure to aid in the alignment and positioning of the advancement element and help maintain the advancement element in place during translation of the advancement element. The modification would yield the same predictable results pertaining to advancement element translation through the body of the device during. As modified, the bottom half of the inside of assembly 220 of Palushi would include channel 656 of Ha, with catheter 270 disposed therein and slider 226 disposed on top of channel 656.
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Regarding claim 2, Palushi, as modified, discloses all the limitations of claim 1. Palushi further discloses the vascular access device wherein the groove is linear (the bottom half of the inside of assembly 220 of Palushi, including channel 656 of Ha, is linear, see Fig. 5 and 7A-7C of Palushi)
Regarding claim 3, Palushi, as modified, discloses all the limitations of claim 1. Palushi further discloses the vascular access device wherein the support feature is disposed on top of the groove (slider 226 is disposed in the top half of assembly 220, which is on top of the bottom half of assembly 220, including channel 656 of Ha, see Fig. 5 and 7A of Palushi), wherein in response to movement of the advancement element from the retracted position to the advanced position, the advancement element contacts a proximal end of the support feature and pushes the support feature distally along the groove ([0058] and [0060] & Fig. 7A-7C; slider 222 contacts the proximal end of slider 226 upon advancement of slider 222 and pushes slider 226 along the length of the bottom half of assembly 220, including channel 656 of Ha).
Regarding claim 4, Palushi discloses all the limitations of claim 3. Palushi further discloses the vascular access device further comprising an arm extending from the proximal end of the support feature (the section of member 260 between slider 226 and slider 222, as seen in Figure 7A, is being interpreted as the arm; this section extends from a proximal end of slider 226), wherein the arm is configured to extend through the advancement element (the arm is configured to extend through slider 222, see Fig. 7A-7C), wherein in response to movement of the advancement element from the retracted position to the advanced position, the advancement element slides distally along the arm until the advancement element contacts the proximal end of the support feature (slider 222 slides along the arm until it contacts the proximal end of slider 226, see Fig. 7A-7C).
Regarding claim 5, Palushi discloses all the limitations of claim 4. Palushi further discloses the vascular access device wherein in response to movement of the advancement element from the advanced position to the retracted position (see Fig. 7C-7E), the advancement element pulls the arm and the support feature proximally (slider 222, while moving back to the retracted position of Figure 7A and 7E, pulls slider 226 and the arm proximally, [0063]).
Regarding claim 6, Palushi discloses all the limitations of claim 5. Palushi further disclose the vascular access device wherein a proximal end of the arm comprises a hook (in the decoupled configuration of the sliders 222 and 226, as seen in Figure 7A, the proximal end of the arm comprises a hook 224, [0063]), wherein in response to movement of the advancement element from the advanced position to the retracted position, the advancement element catches on the hook and pulls the arm and the support feature proximally (while slider 222 moves from the advanced position to the retracted position (Fig. 7D), it is caught on latch 224, which allows slider 222 to pull the arm and slider 226 proximally, see [0063]).
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
In response to Applicant's arguments that the Examiner did not fully respond to arguments directed toward the new limitation of “wherein the support feature is positioned distally from the advancement element”, the Examiner finds that the limitation was a new limitation that was rejected with a new teaching, and a new annotated Figure, which rendered the arguments directed toward this new limitation moot. The new ground of rejection did not rely on any reference applied in the prior rejection for any teaching specifically challenged in the argument.
Applicant’s arguments with respect to claim(s) 1, regarding a groove, wherein the groove is a depression in the inner surface of the housing, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to Applicant’s arguments that slider 226 could not limit displacement of the instrument from the groove, the Examiner finds slider 226 must be displaced in order for member 270 to be further moved out of instrument 210, or in other words displaced from the groove. The positioning of slider 226 directly affects the movement of slider 222, which directly affects the displacement of member 270. Slider 226 directly affects the movement path of slider 222 and must be displaced in combination with slider 222 in order to facilitate continued, further displacement of member 270. The Examiner also notes that sliders 226 and 222, including member 270, are not moved by the same force throughout the entirety of the movement path of sliders 226 and 222.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the support feature interacting directly with the instrument) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, slider 226 limits displacement of the instrument from the groove considering slider 226 must be displaced in order for the instrument to exit the device, or leave the groove.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783