DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 03/30/2026. As directed by the amendment: claims 1, 8 have been amended; no claims have been canceled; and new claims 17-22 have been added. Thus, claims 1-22 are presently pending in this application.
Applicant’s amendments to claims have overcome the 112(b) rejections previously set forth in the office action mailed 11/05/2025.
Response to Arguments
Applicant’s argument pages 8-11 of the remarks filed 03/30/2026 that Grace does not disclose an indicator configured to be visible only when the instrument is in the advanced position since the indicator of Grace will be visible to indicate a movement of the blade or cutting edge 4622, however, the blade may have: 1) not extended beyond the distal end of the outer sheath, or 2) may have moved a distance within the inner sheath toward the proximal end of the outer sheath. Applicant’s argument has been fully considered and are not persuasive. Grace discloses in par. 0207 that the device comprises an indicator indicative of how far the blade of the inner cam member has traveled beyond the distal end of the outer sheath. Grace also discloses in par. 0207 that indicator may include indicia, such as numbers or dimension indicative of the length that the blade has traveled beyond the distal end of the outer sheath; in addition and/or in lieu of the indicia, the indicator may include color coded regions (e.g., green, yellow, orange, red, etc.), such that differently colored regions convey to the clinician … whether the cutting blade is exposed and/or how much of it is exposed. Therefore, Grace discloses the numbers or dimensions indicative of the length of the blade visible only when the blade has traveled beyond the distal end of the outer sheath, and Grace also discloses the color coded regions (e.g., green, yellow, orange, red, etc.) indicative whether the blade is exposed and/or how much of it is exposed visible only when the blade has traveled beyond the distal end of the outer sheath. Therefore, Grace discloses the limitation “the indicator configured to be visible only when the instrument is in the advanced position”.
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, 12, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grace (US 2015/0105796).
Regarding claim 1, Grace discloses
An instrument advancement device (device shown in figs. 1-48D with an embodiment of the handle portion including an indicator shown in one of the embodiments in figs. 24-27 and pars. 0207-0208) for advancing an instrument (inner sheath 426 with inner cam member 412 and blade, see figs. 4B-4C and pars. 0144-0147) through a vascular access device (Examiner notes: the limitation “for advancing an instrument through a vascular access device” is interpreted as functional limitation, and the limitation “a vascular access device” is not positively recited in claim 1. See figs. 4A-4C for the shape of 426 such that 426 is capable of being advanced through a vascular access device), the device comprising:
a housing (outer sheath 404 as shown in figs. 4B-4C) comprising a distal end (distal end of 404– toward the insertion site) and a proximal end (proximal end of 404 – away from the insertion site), the distal end (distal end of 404) is configured to couple to the vascular access device (Examiner notes: the limitation “configured to couple to the vascular access device” is interpreted as functional limitation, and the limitation “the vascular access device” is not positively recited in claim 1. See figs. 4B-4C for the shape of 404 such that 404 is capable of being coupled to a vascular access device);
the instrument (426, figs. 4B-4C and pars. 0144-0147) at least partially received within the housing (see figs. 2, 4A-4C, pars. 0144-0147), the instrument (426) having an advanced position where a distal end of the instrument extends beyond the distal end of the housing (see fig. 4C) and a retracted position where the distal end of the instrument is received within the housing (see fig. 4B);
an actuator (212, fig. 2 and pars. 0138-0140, 0146-0147) configured to move the instrument (426) between the advanced position (see fig. 4C) and the retracted position (see fig. 4B); and
an indicator (2440 in fig. 24, 2540 in fig. 25, 2640 in fig. 26, or 2740 in fig. 27. See also par. 0207) configured to be visible only when the instrument is in the advanced position (Examiner notes: see par. 0207 for 2440 indicating how far the blade of the inner cam member has traveled and/or has traveled beyond the distal end of the outer sheath wherein 2440 includes indicia such as numbers or dimensions indicative of the length that the blade has traveled and/or has traveled beyond the distal end of the outer sheath. Therefore, 2440 is visible only when the blade is traveled and/or is traveled beyond the distal end of the outer sheath).
Regarding claim 12, Grace discloses
The device of claim 1, wherein the indicator comprises a light (see par. 0208).
Regarding claim 16, Grace discloses
The device of claim 1, wherein the indicator (2640) comprises an indicator member (2638), wherein the indicator member is rotatable relative to the housing (see par. 0208 for 2640 being position on a gear and see par. 0136 for the gear to be rotated to advance the instrument), and wherein the indicator member is configured to rotate to be visible when the instrument is in the advanced position (see fig. 26 and pars. 0136 and 0208).
Claim Rejections - 35 USC § 103
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 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) 1-3, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al. (US 2018/0317830) in view of Grace (US 2015/0105796).
Regarding claim 1, Devgon discloses
An instrument advancement device (6000, figs. 9-14 and pars. 0102-0121) for advancing an instrument (6200, fig. 10) through a vascular access device (6300, see figs. 9-14), the device (6000) comprising:
a housing (6100) comprising a distal end (6230, fig. 10) and a proximal end (6220, fig. 10), the distal end (6230) is configured to couple to the vascular access device (6300, see figs. 9-14);
an instrument (6200) at least partially received within the housing (6100, see figs. 9-14), the instrument (6200) having an advanced position (figs. 12-13) where a distal end of the instrument extends beyond the distal end of the housing (see figs. 12-13) and a retracted position (figs. 11 and 14) where the distal end of the instrument is received within the housing (see figs. 11 and 14);
an actuator (6500) configured to move the instrument (6200) between the advanced position and the retracted position (see figs. 11-14).
Devgon is silent about an indicator configured to be visible only when the instrument is in the advanced position.
However, Grace teaches an indicator (Examiner notes: Graces teaches different embodiments of the indicator – see figs. 24-27 for indicators 2440, 2540, 2640, and 2740) configured to be visible only when the instrument is in the advanced position (see pars. 0207-0209 for indicators indicating how far the blade of the inner cam member has traveled and/or has traveled beyond the distal end of the outer sheath wherein the indicator includes indicia such as numbers or dimensions indicative of the length that the blade has traveled and/or has traveled beyond the distal end of the outer sheath. Therefore, the indicator is visible only when the blade is traveled and/or is traveled beyond the distal end of the outer sheath).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Devgon’s device by adding an indicator to the device, as taught by Grace, for the purpose of indicating how far the distal end of the instrument has traveled beyond the distal end of other element (pars. 0207-0209 of Grace).
Regarding claim 2, Devgon in view of Grace discloses the device of claim 1,
Grace further teaches wherein the housing (2404, fig. 24) comprises a viewing window (window of 2404, see fig. 24), wherein the indicator (2440) is aligned with the viewing window when the instrument is in the advanced position (pars. 0207-0209) (Examiner notes: see also embodiment in fig. 25 teaching indicator 2540 aligning with the viewing window of housing 2504).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Devgon’s device by adding a viewing window to housing 6100 of Devgon, as taught by Grace, for the purpose of allowing the user to view the indicator to indicate how far the distal end of the instrument has traveled beyond the distal end of other element (pars. 0207-0209 of Grace).
Regarding claim 3, Devgon in view of Grace discloses the device of claim 2,
Grace further teaches wherein the indicator (2440, fig. 24) comprises a first color or pattern (as shown in fig. 24) and the housing (2404) comprises a second color or pattern (as shown in fig. 24), and wherein the first color or pattern is different than the second color or pattern (see fig. 24 and pars. 0207-0209).
Regarding claim 12, Devgon in view of Grace discloses the device of claim 1,
Grace further teaches wherein the indicator comprises a light (see par. 0208).
Regarding claim 13, Devgon in view of Grace discloses the device of claim 12,
Devgon further discloses wherein the instrument (6200) comprises a guidewire (6200, figs. 9-14).
Grace further teaches wherein a portion of the instrument is configured to activate the light when the instrument is moved to the advanced position (see par. 0208 for the indicator/light being actuated when the color of the light and/or the brightness of the light is changed as the distal end of the instrument travels from its retracted position to its extended position).
Claim(s) 7, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al. (US 2018/0317830) in view of Grace (US 2015/0105796) in further view of Bagaoisan et al. (US 2014/0018732).
Regarding claim 7, Devgon in view of Grace discloses the device of claim 1, as set forth above, except for wherein the housing comprises a viewing window, wherein the indicator comprises a visualization portion of the instrument, and wherein the visualization portion of the instrument is aligned with the viewing window when the instrument is in the advanced position.
However, Bagaiosan teaches the housing (403/405, figs. 4A-4B) comprising a viewing window (404), wherein the indicator (indicators/markers on 402) comprises a visualization portion of the instrument (portion of 402), and wherein the visualization portion of the instrument is aligned with the viewing window when the instrument (402) is in the advanced position (see figs. 4A-4B).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Devgon’s device such that the indicator is positioned on a portion of the instrument such that the indicator is visualized when the instrument is in the advanced position, as taught by Bagaiosan, for the purpose of providing the user with an indicator of the distal end of the instrument (par. 0126 of Bagaiosan).
Regarding claim 10, Devgon in view of Grace and Bagaiosan discloses the device of claim 7,
Bagaiosan further teaches wherein the visualization portion of the instrument comprises a straight or cylindrical portion of the instrument (see figs. 4A-4B).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Devgon’s device such that the indicator is positioned on a portion of the instrument such that the indicator is visualized when the instrument is in the advanced position, as taught by Bagaiosan, for the purpose of providing the user with an indicator of the distal end of the instrument (par. 0126 of Bagaiosan).
Regarding claim 11, Devgon in view of Grace and Bagaiosan discloses the device of claim 7,
Bagaiosan further teaches wherein the visualization portion of the instrument comprises a color, marking, and/or indicia distinct from a remaining portion of the instrument (see figs. 4A-4B and par. 0126).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al. (US 2018/0317830) in view of Grace (US 2015/0105796) and Bagaoisan et al. (US 2014/0018732) in further view of Cronenberg et al. (US 2017/0354781).
Regarding claim 8, Devgon in view of Grace and Bagaoisan discloses the device of claim 7, as set forth above, except for wherein the viewing window comprise a magnification element.
However, Cronenberg teaches the indicator window (30, figs. 1-4) comprising a magnifying lens for providing a clear view of the indicator arrangement (par. 0143).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Devgon’s device such that the viewing window comprising a magnifying lens, as taught by Cronenberg, for the purpose of providing a clear view of the indicator arrangement (par. 0143 of Cronenberg).
Allowable Subject Matter
Claim(s) 4-6, 9, 14-15 is/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.
Claims 17-22 are allowed over the prior art of records.
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to disclose or teach either singly or in combination the claimed system.
The closest prior art of records is Grace (US 2015/0105796).
Regarding independent claim 17, the cited prior art fails to disclose/teach among all the limitation or render obvious an instrument advancement device in combination with the total structure and function as claimed. No combination of prior art was found to teach or suggest each and every element of independent claim 17.
Grace is silent about the actuator comprising an advancement member, a portion of the advancement member moveable along an outer surface of the housing, wherein the indicator comprises indicia, and wherein the indicia is covered by the advancement member when the instrument is in the retracted position and uncovered by the advancement member when the instrument is in the advanced position.
Regarding independent claim 22, the cited prior art fails to disclose/teach among all the limitation or render obvious an instrument advancement device in combination with the total structure and function as claimed. No combination of prior art was found to teach or suggest each and every element of independent claim 22.
Grace is silent about the instrument comprising a guidewire, and wherein the visualization portion of the instrument comprises a coiled portion of the guidewire, the coiled portion of the guidewire having a compressed shape when the instrument is in the advanced position and a non-compressed shape when the instrument is in the retracted position.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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