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
The Amendment filed 8/19/2026 has been entered. Claims 1-9 and 15-25 remain pending in the application.
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.
Claims 1-9, 15, 16 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Carrez et al. (US 2007/0249980 A1) in view of Xiao (US 2021/0146097 A1).
Regarding claim 1, Carrez discloses a catheter securement device 1 (figures 1 and device shown in figure 4) comprising:
a base 1b defining a slot 6; and
at least one inertial damper 1a attached to the base 1b and extending above the slot 6, the at least one inertial damper 1a comprising at least one channel 7, 8, 9, 10 passing through the at least one inertial damper 1a, the at least one channel 7, 8, 9, 10 defined by sidewalls (see “SS” in figure 5 below),
the slot 6 and the at least one inertial damper 1a being relatively positioned so that when the slot 6 is aligned over a catheter insertion site (site where a catheter gets inserted), a catheter tube (see solid line representing catheter in figure 7) exiting the catheter insertion site is receivable through the slot 6, passable through at least one channel 7, 8, 9, 10 and coilable around at least a portion of the at least one inertial damper 1a (see figure 7, similarly, catheter tube could be coiled around 1a in figure 1).
Carrez is silent regarding the sidewalls being undulating sidewalls that form a series of channel sections of alternating width, the series of channel sections of alternating width comprising a plurality of constricted sections having a first width and a plurality of widened sections having a second width larger than the first width.
However, Xiao teaches a design of a catheter positioning device (figure 1D) comprising undulating sidewalls (sidewall of element 13) that form a series of channel sections of alternating width (see figure 1D where presence of element 131 will make alternating width), the series of channel sections of alternating width comprising a plurality of constricted sections (sections with smaller width) having a first width and a plurality of widened sections (sections with larger width due to element 131) having a second width larger than the first width for the purpose of securely hold the catheter in the position without compromising the constriction of the catheter (paragraph 0003, lines 6-27).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the channel of Carrez to incorporate undulating sidewalls that form a series of channel sections of alternating width, the series of channel sections of alternating width comprising a plurality of constricted sections having a first width and a plurality of widened sections having a second width larger than the first width as taught by Xiao for the purpose of securely hold the catheter in the position without compromising the constriction of the catheter (paragraph 0003, lines 6-27).
PNG
media_image1.png
570
738
media_image1.png
Greyscale
Regarding claim 2, Carrez teaches wherein the slot 6 and the at least one inertial damper 1a are relatively positioned so that the catheter tube (solid line representing catheter in figure 7) is coilable around the at least one inertial damper 1a to fully surround the at least one inertial damper 1a (see figure 7).
Regarding claim 3, Carrez teaches wherein the at least one inertial damper 1a (figures 1 and 5) comprises a peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5) configured to frictionally (paragraph 0034) engage the catheter tube.
Regarding claim 4, Carrez teaches wherein the peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5) is compressible under stored energy (paragraph 0034, “elastic trapping”, paragraph 0036, “flexible and elastic” material would be compressible).
Regarding claim 5, Carrez teaches wherein the slot 6 and the peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5) are relatively positioned so that when the slot is aligned over the catheter insertion site, the catheter tube (figure 7) exiting the catheter insertion site is receivable through the slot 6 and coilable around at least a portion of the peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5).
Regarding claim 6, Carrez teaches wherein the peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5) comprises a plurality of sidewall sections (see “SS” in figure 5 above).
Regarding claim 7, Carrez teaches wherein the slot 6 and the peripheral sidewall (wall of elements 1a forming channels 7, 8, 9 and 10, elements 9 and 10 are present in embodiment shown in figure 5) are relatively positioned so that when the slot 6 is aligned over the catheter insertion site, the catheter tube exiting the catheter insertion site is receivable through the slot 6 and coilable (figure 7) around some or all of the plurality of sidewall sections (see “SS” in figure 5 above).
Regarding claim 8, Carrez teaches further comprising at least two coil retaining members (1a can also serve as coil retaining members) configured to keep the catheter tube coiled around the at least one inertial damper 1a (by coiling the catheter tube around 1a in figures 1 or 5 and reinserting/inserting in a channel, element 1a is capable to keep the catheter tube coiled around the at least one inertial damper).
Regarding claim 9, Carrez teaches wherein each of the at least two coil retaining members 1a configured to limit (see figure 7 where element 1a is capable to limit migration of the catheter tube) migration of the catheter tube away from the peripheral sidewall after the catheter tube is coiled around the at least one inertial damper 1a.
Regarding 15, Carrez teaches wherein the at least one inertial damper 1a comprises a first lateral inertial damper (see “FD” in figure 5A below), a second lateral inertial damper (see “SD” in figure 5A below), and at least one medial inertial damper (see “MD” in figure 5A below) between the first lateral inertial damper (see “FD” in figure 5A below) and the second lateral inertial damper (see “SD” in figure 5A below), and wherein the at least two coil retaining members comprise the first lateral inertial damper (see “FD” in figure 5A below) and the second lateral inertial damper (see “SD” in figure 5A below).
PNG
media_image2.png
570
738
media_image2.png
Greyscale
Regarding claim 16, Carrez teaches wherein the at least one channel comprises a first channel 9 and a second channel (10 or 7), wherein the first lateral inertial damper (see “FD” in figure 5A above) and the at least one medial inertial damper (see “MD” in figure 5A above) are separated by the first channel 9, wherein the second lateral inertial damper (see “SD” in figure 5A above) and the at least one medial inertial damper (see “MD” in figure 5A above) are separated by the second channel (10 or 7), and wherein the first channel 9 and the second channel (10 or 7) are configured such that the catheter tube is coilable (figure 7) around the at least one medial inertial damper (see “MD” in figure 5A above) through the first channel 9 and the second channel (10 or 7).
Regarding claim 21, Carrez is silent regarding wherein the plurality of constricted sections are configured to frictionally engage the catheter tube when the catheter tube is inserted through the at least one channel, while the plurality of widened sections are configured to be wider than the catheter tube, so that the catheter tube encounters limited frictional resistance from only a portion of the undulating sidewalls during insertion.
However, Xiao teaches wherein the plurality of constricted sections (sections with smaller width) are configured to frictionally engage the catheter tube (sections with smaller width are configured to provide frictional engagement) when the catheter tube is inserted through the at least one channel, while the plurality of widened sections (sections with larger width due to presence of element 131 will not touch the catheter tube) are configured to be wider than the catheter tube, so that the catheter tube encounters limited frictional resistance from only a portion of the undulating sidewalls during insertion for the purpose of securely hold the catheter in the position without compromising the constriction of the catheter (paragraph 0003, lines 6-27).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the channel of Carrez to incorporate wherein the plurality of constricted sections are configured to frictionally engage the catheter tube when the catheter tube is inserted through the at least one channel, while the plurality of widened sections are configured to be wider than the catheter tube, so that the catheter tube encounters limited frictional resistance from only a portion of the undulating sidewalls during insertion as taught by Xiao for the purpose of securely hold the catheter in the position without compromising the constriction of the catheter (paragraph 0003, lines 6-27).
Regarding claim 22, Carrez discloses wherein the at least one channel 7, 8, 9, 10 extends linearly along a longitudinal axis (at least one of the channels 7, 8, 9 and 10 extends linearly along a longitudinal axis which could be an axis parallel to one of elements 7, 8, 9, 10) with sidewalls (see “SS” in figure 5 above) arranged symmetrically with respect to the longitudinal axis but is silent regarding the sidewalls being undulating sidewalls.
However, as explained in the rejection of claim 1 above, Carrez modified in view of Xiao would result in having the sidewalls being undulating sidewalls.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carrez et al. (US 2007/0249980 A1) in view of Xiao (US 2021/0146097 A1) and further in view of Mogensen et al. (US 7,115,112 B2).
Regarding claims 17 and 18, Carrez/Xiao (hereinafter referred as “modified Carrez”) discloses the claimed invention substantially as claimed, as set forth above in claims 1, 3, 8 and 15 above. Carrez further discloses the structure (figure 5) that allows retaining the catheter tube in the position (paragraph 0041, lines 5-6) wherein the at least one channel further comprises a third channel (10 or 7) but is silent regarding wherein the at least one medial insertial damper comprises a first medial inertial damper and a second medial inertial damper, wherein the first medial inertial damper and the second medial inertial damper are separated by a third channel, and wherein the first channel, the second channel, and the third channel are each configured such that the catheter tube is coilable around the first medial inertial damper and the second medial inertial damper through the first channel, the second channel and the third channel wherein the first channel, the second channel and the third channel are parallel.
However, Mogensen teaches a design of a catheter holder 10 (figure 4b) wherein the at least one medial insertial damper (see “MD” in figure 4a below) comprises a first medial inertial damper (see “FMD” in figure 4a below) and a second medial inertial damper (see “SMD” in figure 4a below), wherein the first medial inertial damper (see “FMD” in figure 4a below) and the second medial inertial damper (see “SMD” in figure 4a below) are separated by the third channel (channel occupied by element 24), and wherein the first channel (channel occupied by element 14), the second channel (see “SC” in figure 4a below), and the third channel (channel occupied by element 24) are each configured such that the catheter tube is coilable (see figure 4b) around the first medial inertial damper (see “FMD” in figure 4a below) and the second medial inertial damper (see “SMD” in figure 4a below) through the first channel (channel occupied by element 14), the second channel (see “SC” in figure 4a below) and the third channel (channel occupied by element 34) wherein the first channel (channel occupied by element 14), the second channel (see “SC” in figure 4a below) and the third channel (channel occupied by element 24) are parallel (see figure 4b) for the purpose of using an alternative configuration to securely hold the catheter tube in position (column 3, lines 27-37).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the arrangement of the inertial damper of Carrez to incorporate wherein the at least one medial insertial damper comprises a first medial inertial damper and a second medial inertial damper, wherein the first medial inertial damper and the second medial inertial damper are separated by a third channel, and wherein the first channel, the second channel, and the third channel are each configured such that the catheter tube is coilable around the first medial inertial damper and the second medial inertial damper through the first channel, the second channel and the third channel wherein the first channel, the second channel and the third channel are parallel as taught by Mogensen for the purpose of using an alternative configuration to securely hold the catheter tube in position (column 3, lines 27-37).
PNG
media_image3.png
218
316
media_image3.png
Greyscale
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Carrez et al. (US 2007/0249980 A1) in view of Xiao (US 2021/0146097 A1) and further in view of Fleischer (US 2010/0121280 A1).
Regarding claim 20, Carrez discloses the claimed invention substantially as claimed, as set forth above in claim 1. Carrez is silent regarding further comprising a clear dressing configured to cover the base, the at least one inertial damper and the slot.
However, Fleischer teaches a design of a catheter securement device (figure 1) comprising a clear dressing 5a (paragraph 0049, lines 6-8) configured to cover the base 5b, the at least one inertial damper 12 and the slot 11 for the purpose of covering the catheter securement device thereby reducing the risk of infection (paragraph 0043, lines 5-9) and to visually inspect the incision site without removing the securement device (paragraph 0049, lines 6-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the catheter securement device of Carrez to incorporate a clear dressing configured to cover the base, the at least one inertial damper and the slot as taught by Fleischer for the purpose of covering the catheter securement device thereby reducing the risk of infection (paragraph 0043, lines 5-9) and to visually inspect the incision site without removing the securement device (paragraph 0049, lines 6-8).
Allowable Subject Matter
Claims 23-25 are allowed.
Claim 19 is 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.
The following is an examiner’s statement of reasons for allowance:
Claim 19 was previously indicated allowable in the Office Action mailed on 5/19/2026 if rewritten in an independent form.
Claim 19 was previously indicated allowable in the Office Action mailed on 5/19/2026 if claim 19 is rewritten in an independent form. Claim 23, as currently presented, is an independent form of claim 19.
Claims 24 and 25 being dependent on claim 23 are also allowed.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM 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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
