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 in response to the amendment filed on 1/22/2026. Currently claims 1-18 are pending.
Response to Arguments
Applicant's arguments, see pgs. 6-11 filed 1/22/2026 with respect to the rejection(s) of claim(s):
1-2, 6-11, 13 and 15-18 under 35 USC 102(a)(1) as being anticipated Beard
3-5, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beard
have been fully considered but they are not persuasive.
Applicant argues that Beard fails to disclose all the limitations of the independent claims for one or more of the following reasons:
Beard fails to teach the plurality of slack pockets isolating the plurality of slack loops as claimed
Beard fails to teach a slack loop in each slack pocket as claimed
Beard fails to teach isolating the plurality of slack loops each other defines the slack in the system
[see pgs. 7-11 of applicant’s arguments received on 1/22/2026]
In response, these arguments are not persuasive. In particular, applicant’s arguments are not commensurate with the scope of the claims. First, based on applicant’s arguments, applicant argues that isolate means two slack loops do not interact with each other. As applicant argues:
“the slack 810 between two respective bottom pins 710 (i.e., the Examiner's defined "slack pockets") may interact with adjacent slack 810 between adjacent bottom pins 710. In other words, Beard's bottom pins 710 alone do not isolate slack loops from each other.” [see pg. 7 of applicant’s arguments received on 1/22/2026].
There does not appear to be a special definition for “isolate” in applicant’s specification so the broadest reasonable interpretation taken is the dictionary interpretation. Merriam-Webster defines “isolate” as including the definition: “to set apart from others” [see attached definition].
The loops are set apart from each other by remaining pins as shown in Fig. 20 Beard. Thus, under broadest reasonable interpretation Beard’s loops are isolated. Second, while the exact interpretation applicant takes for pocket is not explicitly stated in the arguments, applicant appears to have a narrower interpretation for the term “pocket”. There does not appear to be a special definition for “pocket” in applicant’s specification so the broadest reasonable interpretation taken is the dictionary interpretation. Merriam-Webster defines “pocket” as including the definition of “a small often isolated area or group”. The space between the remaining pins as shown in labelled Figure 19 of Beard directly below the rejection of claim 1 in both the previous rejection and current rejection in the office action below is understood to be a pocket as this area is isolated (or set apart from each other) by the pins. Thus, Beard has a pocket as claimed. Third, the last argument is based on more narrow interpretations of “isolated” and “pockets”. As explained in the two previous points by removing the top pins the loops are formed in an isolated manner by the spacing of the lower pins which results in slack that is “isolated” in “pockets” as interpreted under broadest reasonable interpretation. The fact that an extra step of removing the top pins occurs to position line is irrelevant as all the apparatus and method claims use open transitional phrase of “comprising” (indicating additional features can be present) and none of the claims exclude the removal of pins. So since the last argument is based on more narrow interpretations of “isolated” and “pockets”, this argument is not commensurate in scope either. Thus, these arguments, are not persuasive and the rejections have been maintained.
While the rejection has been maintained based on the claim language being broader than what applicant argues, depending on the exact language used, if applicant has support in the specification for these more specific argued features and clarifies the claims to include these more specific features as argued, applicant could probably overcome the current prior art rejections.
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.
Claim(s) 1-2, 6-11, 13 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beard et al (US 20150282881) hereafter known as Beard.
Independent claim
Regarding claim 1:
A slack storage system for a system line in a medical device [see Figs. 1 and 17-21 element 100 and para 21…“The introducer assembly 100” and abstract… “An introducer assembly having a handle, at least one fiber operatively coupling at least one handle with one or more functions of the handle; and having a fiber routing system that allows a predetermined amount of slack to be created during assembly”], the slack storage system comprising:
a plurality of slack pockets arranged in series [see slack pockets in labelled figure(s) directly below rejection to this claim]; and
a system line [see Fig. 18-21 element 800 and para 46… “a fiber 800”] having a first end and a second end [see first end and second end of system lines in labelled figure(s) below rejection to this claim] with a portion of the system line between the first end and the second end defining a slack loop in each slack pocket [see labelled slack loops in the labelled figure(s) below rejection to this claim], the plurality of slack pockets isolating the plurality of slack loops from each other to define slack in the system line [see how the loops are positioned relative to the pockets in the labelled figure(s) below] such that when the first end of the system line is tensioned the second end of the system line remains untensioned as the slack in the system line is dispensed by each slack loop straightening from each slack pocket without tangling with another one of the slack loops [see transition of element 800 (i.e. line) from Fig. 18-21 and para 45… “An introducer assembly, in accordance with other embodiments, can utilize fibers for operatively coupling handle knobs with the various functions of the handle and can include a fiber routing system that allows a predetermined amount of slack to be created during assembly in one or more of the fibers so as to delay by a desired amount of time actuation of the functions of the handle associated with the one or more of the fibers during operation of the handle.” And para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”].
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Independent claim:
Regarding claim 9
A method for providing slack in a system line for a medical device [see Figs. 17-20 and para 18… “FIGS. 18-21 are enlarged perspective views illustrating a sequence of routing fibers about pins of the fiber routing system of FIG. 17 and tensioning of the fibers in use” and para 46… “After routing the fiber 800, the one or more stagger pins 710 can be withdrawn or otherwise removed from the apertures 712, as illustrated by the sequence of FIGS. 18-21, resulting in slack 810 in the fiber 800.”], the method comprising:
positioning a system line adjacent to a series of slack pockets of a slack storage system [see Figs. 17-20 and labelled figures below rejection to this claim with labelled slack pockets, element 800 is a system line, element 700 is a slack storage system and para 21… “The introducer assembly 100 includes a sheath 200 and a handle 300.” And para 46… “a fiber 800” and para 45… “The fiber routing system 700”]; and
positioning at least one of a plurality of portions of the system line in at least one of the series of slack pockets of the slack storage system to form at least one slack loops [see Figs. 17-20 and labelled figures below rejection to this claim with labelled slack loops],
wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line [see Fig. 20 and labelled figure(s) which shows first and second end of line below rejection to this claim And para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”]
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Independent claim:
Regarding claim 15
An apparatus to store slack in a system line [see Figs. 1 and 17-19 element 100 and para 21…“The introducer assembly 100” and abstract… “An introducer assembly having a handle, at least one fiber operatively coupling at least one handle with one or more functions of the handle; and having a fiber routing system that allows a predetermined amount of slack to be created during assembly”], the apparatus comprising:
a plurality of slack pockets arranged in series [see slack pockets in labelled figure(s) below rejection to this claim];
wherein the system line [see Fig. 18-21 element 800 and para 46… “a fiber 800”] is configured to form a slack loop within each slack pocket, the plurality of slack pockets isolating the slack loops from each other [see labelled slack loops in the labelled figure(s) below rejection to this claim and see how the loops are positioned relative to the pockets in the labelled figure(s)]; and
wherein the plurality of slack pockets are configured such that when tension is applied to the system line, slack is dispensed by each slack loop straightening from each slack pocket without tangling with another of the slack loops [see transition of element 800 (i.e. line) from Fig. 18-21 and para 45… “An introducer assembly, in accordance with other embodiments, can utilize fibers for operatively coupling handle knobs with the various functions of the handle and can include a fiber routing system that allows a predetermined amount of slack to be created during assembly in one or more of the fibers so as to delay by a desired amount of time actuation of the functions of the handle associated with the one or more of the fibers during operation of the handle.” and para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”].
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Independent claim:
Regarding claim 16
A method for providing slack in a system line [see Figs. 17-20 and para 18… “FIGS. 18-21 are enlarged perspective views illustrating a sequence of routing fibers about pins of the fiber routing system of FIG. 17 and tensioning of the fibers in use” and para 46… “After routing the fiber 800, the one or more stagger pins 710 can be withdrawn or otherwise removed from the apertures 712, as illustrated by the sequence of FIGS. 18-21, resulting in slack 810 in the fiber 800.”], the method comprising:
positioning a system line adjacent to a series of slack pockets of a slack storage system [see Figs. 17-20 and labelled figures below rejection to this claim with labelled slack pockets, element 800 is a system line, element 700 is a slack storage system and para 21… “The introducer assembly 100 includes a sheath 200 and a handle 300.” And para 46… “a fiber 800” and para 45… “The fiber routing system 700”]; and
positioning at least one of a plurality of portions of the system line in at least one of the series of slack pockets of the slack storage system to form at least one slack loop [see Figs. 17-20 and labelled figures below rejection to this claim with labelled slack loops],
wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line [see Fig. 20 and labelled figure(s) which shows first and second end of line below rejection to this claim and para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”];
wherein the at least one portion of the system line is positioned within the at least one slack pocket with a finger-shaped element [see Figs. 17-20 and see para 45… “For example, as shown in FIG. 17, a fiber routing system is shown and generally indicated at 700. The fiber routing system 700 includes a series of vertical pins 710 about which one or more fibers can be routed.” The pins as shown in Figs. 17-20 are finger shaped elements].
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Independent claim
Regarding claim 17
An apparatus to store slack in a system line for a medical device [see Figs. 1 and 17-21 element 100 and para 21…“The introducer assembly 100” and abstract… “An introducer assembly having a handle, at least one fiber operatively coupling at least one handle with one or more functions of the handle; and having a fiber routing system that allows a predetermined amount of slack to be created during assembly”], the apparatus comprising:
a plurality of slack pockets arranged in series [see slack pockets in labelled figure(s) below rejection to this claim]; and
a system line [see Fig. 18-21 element 800 and para 46… “a fiber 800”] forming a slack loop into each slack pocket, the plurality of slack pockets isolating the slack loops from each other [see labelled slack loops in the labelled figure(s) below rejection to this claim and see relationship between loops and pockets in the figure(s) below];
wherein the plurality of slack pockets are configured such that when tension is applied to the system line, slack is dispensed by each slack loop straightening from each slack pocket without tangling with another one of the slack loops [see transition of element 800 (i.e. line) from Fig. 18-21 and para 45… “An introducer assembly, in accordance with other embodiments, can utilize fibers for operatively coupling handle knobs with the various functions of the handle and can include a fiber routing system that allows a predetermined amount of slack to be created during assembly in one or more of the fibers so as to delay by a desired amount of time actuation of the functions of the handle associated with the one or more of the fibers during operation of the handle.” The delay caused by the slack is understood to allow tensioning of the first end while the second end remains untentioned until the slack is straightened and para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”].
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Independent claim
Regarding claim 18
An apparatus to store slack in a system line [see Figs. 1 and 17-21 element 100 and para 21…“The introducer assembly 100” and abstract… “An introducer assembly having a handle, at least one fiber operatively coupling at least one handle with one or more functions of the handle; and having a fiber routing system that allows a predetermined amount of slack to be created during assembly”], the apparatus comprising:
a plurality of slack pockets arranged in series [see slack pockets in labelled figure(s) below rejection to this claim];
a system line [see Fig. 18-21 element 800 and para 46… “a fiber 800”] forming a slack loop into each slack pocket, the plurality of slack pockets isolating the slack loops from each other [see labelled slack loops in the labelled figure(s) below rejection to this claim and see relationship between pockets and loops in labelled figures below]; and
wherein the plurality of slack pockets are configured such that when tension is applied to the system line, slack is dispensed by each slack loop straightening from each slack pocket without tangling with another of the slack loops [see transition of element 800 (i.e. line) from Fig. 18-21 and para 45… “An introducer assembly, in accordance with other embodiments, can utilize fibers for operatively coupling handle knobs with the various functions of the handle and can include a fiber routing system that allows a predetermined amount of slack to be created during assembly in one or more of the fibers so as to delay by a desired amount of time actuation of the functions of the handle associated with the one or more of the fibers during operation of the handle.” The delay caused by the slack is understood to allow tensioning of the first end while the second end remains untentioned until the slack is straightened and para 49… “By removal of the system pins, slack is created into the fiber length so that further fiber displacement produces essentially zero pull force on the opposite end of the fiber.”].
PNG
media_image1.png
610
832
media_image1.png
Greyscale
PNG
media_image2.png
485
916
media_image2.png
Greyscale
Dependent claims:
Regarding claim 2, see labelled figures directly below rejection to claim 1 and Figs. 17-21 of Beard and para 45 of Beard [see… “For example, as shown in FIG. 17, a fiber routing system is shown and generally indicated at 700. The fiber routing system 700 includes a series of vertical pins 710 about which one or more fibers can be routed.”] The bottom pins (bottom elements 710) as shown in Figs. 17-21 are finger shaped elements and are understood to help press the line into the pockets as claimed.
Regarding claim 6, see Figs. 17-21 of Beard and labelled figure directly below rejection to claim 1 which shows the loops extending in a similar direction (i.e. common direction).
Regarding claims 7-8 see labelled figures below rejection to claim 1 and Figs. 17-21 of Beard and para 45 of Beard [see “The fiber routing system 700 includes a series of vertical pins 710 about which one or more fibers can be routed.”] which describe pins (elements 710) that hold the loops. These pins are understood to recite a retainer in the form of a mechanical fastener as recited in claims 7 and 8.
Regarding claim 10, see labelled figures directly below rejection to claim 9 and Figs. 17-20 of Beard and para 45 of Beard [see… “For example, as shown in FIG. 17, a fiber routing system is shown and generally indicated at 700. The fiber routing system 700 includes a series of vertical pins 710 about which one or more fibers can be routed.”] The pins (elements 710) as shown in Figs. 17-21 are finger shaped elements and are understood to help press the line into the pockets as claimed.
Regarding claim 11, see labelled figures directly below rejection to claim 9 and Fig. 20 of Beard which show a total of 3 loops (i.e. at least one additional loop) within 3 slack pockets (i.e. at least one additional slack pocket).
Regarding claim 13, see transition from Fig. 20 to Fig. 21 which shows slack is removed from elements 810 (i.e. loops) which is a form of adjusting the size of the loop therefore modifying the amount of slack stored.
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.
Claim(s) 3-5, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beard.
Regarding claims 3-5:
Beard discloses the invention substantially as claimed including all the limitations of claim 1.
However, Beard is silent as to many of the details of slack loops and slack pockets. Thus, Beard fails to disclose “wherein each of the slack loops are of approximately the same length” as recited by claim 3, “wherein each of the plurality of slack pockets are of approximately the same size and shape” as recited by claim 4 or “wherein the plurality of slack pockets are each evenly spaced from one another” as recited by claim 5.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the positioning of the pins and line such that the slack loops have the same length, the slack pockets have the same size and shape and the slack pockets are evenly spaced from one another (i.e. claims 3-5) because absent unpredictable results these are mere modifications of shape and/or size and/or proportion which have been deemed to be obvious modifications [see In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)]
Regarding claim 12
Beard discloses the invention substantially as claimed including all the limitations of claim 9 as outlined above and a configuration of removing top pins that allow for loops to be formed [ see transition of loops and top elements 710 (top pins) from Figs. 18-20 of Beard and para 46… “After routing the fiber 800, the one or more stagger pins 710 can be withdrawn or otherwise removed from the apertures 712, as illustrated by the sequence of FIGS. 18-21, resulting in slack 810 in the fiber 800. Thus, a tensioning of the fiber 800, illustrated at arrow “d” in FIGS. 18-21, at one end of the fiber 800 results in a shortening of the slack 810 (FIG. 20)”]
However, Beard fails to disclose how the pins are removed and thereby the loops are formed. Therefore, Beard fails to disclose “wherein a plurality of slack loops are formed simultaneously”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Beard by removing the top pins simultaneously, thereby forming the resulting slack loops simultaneously as claimed because there are a limited number of ways to remove the top pins and form the loops (i.e. remove the all top pins at the same time or remove the top pins at different times) and removing all the top pins at the same time is one of those limited number of choices.
Claim 14:
Beard discloses the invention substantially as claimed including all the limitations of claim 9 as outlined above.
Also, Beard is directed to using the slack to delay the time of actuation in certain functions including that of deployment [see abstract…. “An introducer assembly having a handle, at least one fiber operatively coupling at least one handle with one or more functions of the handle; and having a fiber routing system that allows a predetermined amount of slack to be created during assembly in at least one fiber so as to delay by a desired amount of time actuation of the one or more functions of the handle associated with the at least one fiber during operation of the handle.” And para 45… “The fibers can be configured to activate any handle function including steering or deployment of endoluminal devices, or any other function or device requiring remote activation.”]
However, Beard fails to disclose “further including the step of providing assembly verification by feedback when improper tension is detected during slack loop formation” as recited by claim 14.
Beard discloses in another embodiment providing tactile feedback to indicate to the user when different steps in deployment are achieved [see para 30… “Optionally, one or more of the teeth of the gear rack can be sized and/or shaped differently from the other teeth of the gear rack to cause a distinct change in sound, e.g. pitch, or tactile feedback, e.g. clicks, resistance, that indicates to a clinician when a certain step in the deployment is achieved”].
Since Beard is directed to using the slack in the line in deployment and another embodiment of Beard discloses providing tactile feedback throughout different steps the deployment to notify the user when different steps in the deployment are reached, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the first embodiment of Beard by including tactile feedback at different steps of the deployment including when the line is aligned with the pockets and when the loops are formed (i.e. thereby providing assembly verification when either improper or proper tension is detected which recites claim 14) for the purpose of notifying the user as when certain steps of deployment are achieved.
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 SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
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, NIKETA PATEL can be reached at 571-272-4156. 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.
SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights