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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/12/2023, 02/20/2025, and 10/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the figures do not clearly depict the limitations listed in claim 9. It is not well represented in any of the figures the first opening in the proximal surface being smaller than the second opening in the distal surface. For example, Figure 7 depicts a top view of the fixation device, however, only the larger second opening is labeled and depicted. Using broadest reasonable interpretation, by this view point the smaller opening should be able to be seen through the larger opening.
Furthermore, the drawings are objected to because in Figure 52, the reference character 2130 was used twice. One with an associated arrow identifying the sidewall, and the other does not have an associated arrow.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 100 (Fig. 19), 2550 (Figs. 5, 9, 11), and 2560 (Figs. 5, 9).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b)are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: On page 50, line 22, the reference character for channel was incorrectly labeled as 2600, instead of 2500.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 10, 15, 17, 18, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Khalaj (United States Patent No. US 10,195,399 B2), and further in view of Panotopoulos (United States Patent Application Publication No. US 2014/0316366 A1).
Regarding claim 1, Khalaj discloses a fixation device (catheter securement device 10) to secure a catheter tube in a bent configuration relative to a surface of a patient's skin, wherein the fixation device comprises:
a body (base 12) comprising:
a proximal surface (bottom surface 17) which, in use, faces towards the surface of the patient's skin;
a distal surface (top surface 30) which, in use, faces away from the surface of the patient's skin;
a first opening in the proximal surface (FIG. 2, opening 14 from the bottom surface 17 side);
a second opening in the distal surface (FIG. 2, opening 14 from the top surface 30 side);
a sidewall that connects the first opening and the second opening to form a through-hole (FIG. 2, opening 14 crafted through base 12), wherein the sidewall substantially surrounds the through-hole (FIG. 2); and
a channel formed in the distal surface (FIG. 5, slot 24) which, in use, receives a first portion of the catheter tube, wherein the channel is configured such that a distal edge of the first portion of the catheter tube is flush with or recessed from the distal surface when the first portion of the catheter tube is positioned in the channel (FIG. 5, catheter 32 in slot 24),
wherein the fixation device further comprises a retainer configured to retain the first portion of the catheter tube in the channel (FIG. 5, col. 6 lines 11-13 and col. 6 lines 26-30 catheter 32 in slot 24 described as both “secured” and “snug fit”),
wherein the body is configured such that the catheter tube extends in use from the channel through the through-hole to an exit point at which a second portion of the catheter tube exits the patient's skin (FIG. 6), wherein the orientation of the first portion of the catheter tube is substantially different to an orientation of the second portion of the catheter tube (FIG. 6, catheter 32 perpendicular to skin exiting body and parallel to skin after).
Khalaj does not disclose the body is configured such that the sidewall is in use spaced from the exit point to create a window to a region of the patient's skin that substantially surrounds the exit point. However, Panotopoulos teaches the body is configured such that the sidewall is in use spaced from the exit point to create a window to a region of the patient's skin that substantially surrounds the exit point (Fig. 1B and Fig. 2, compartment 70). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter securement device of Khalaj to incorporate a compartment as taught by Panotopoulos to allow to visual access to the placement site of the catheter, making it easier for users to inspect catheter placement.
Regarding claim 2, Khalaj discloses a channel wall forming the channel (FIG. 1, slot 24 has been cut through housing 18 to create channel) therein and wherein the channel wall is configured to act as the retainer (col. 6 lines 11-13 and col. 6 lines 26-30 catheter 32 in slot 24 described as both “secured” and “snug fit”).
Regarding claim 3, Khalaj discloses a distal region of the channel forms a slit (slot 24) which extends from the distal surface to a proximal region of the channel, wherein the slit has a width that is smaller than a width of the first portion of the catheter tube configured to be received in the channel (FIG. 5, col. 6 lines 26-30).
Regarding claim 5, Khalaj does not disclose the retainer comprises a clip. However, Panotopoulos teaches the retainer comprises a clip (clasping means 51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slot of Khalaj to include a clasping means as taught by Panotopoulos in order that the catheter remains in the channel and reduces the risk of the catheter coming out the top side of the channel.
Regarding claim 10, Khalaj does not disclose the sidewall is shaped to form a chamber around the exit point in use. However, Panotopoulos teaches the sidewall is shaped to form a chamber around the exit point in use (Fig. 2 [0031], compartment 70 partially surrounds the insertion site). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the cover member of Khalaj to instead present as an open, rounded compartment as taught by Panotopoulos in order to provide protection for the exit site of the catheter while also allowing for the site to be seen at all time for monitoring.
Regarding claim 15, Khalaj discloses the body further comprises one or more protrusions configured to grip a dressing positioned on or proximate the exit point (FIG. 2, lip 15).
Regarding claim 17, Khalaj discloses the body is configured such that, when the first portion of the catheter tube is received in the channel in use, the catheter tube exits and extends away from the body in a substantially parallel direction to the patient's skin (FIG. 6, catheter 32 perpendicular to skin exiting body and parallel to skin after).
Regarding claim 18, Khalaj discloses the channel is a first channel which may, in use, receive a first portion of the catheter tube (FIG. 5, catheter 32 in slot 24), and the body further comprises a second channel formed in the distal surface (FIG. 5, alternative channels that are not depicted to have tubing through them) which, in use, may receive the first portion of the catheter tube (col. 6 lines 22-25) as an alternative to the first portion of the catheter tube being received in the first channel, wherein the first channel is configured such that the catheter tube extends away from the body in a first direction (FIG. 5, catheter 32 in slot 24) when the first portion of the catheter tube is positioned in the first channel, and the second channel is configured such that the catheter tube extends away from the body in a second direction (col. 6 lines 22-25, catheter positioned in slot dependent on desired direction) when the first portion of the catheter tube is positioned in the second channel, wherein the first direction is substantially different from the second direction (Fig. 5, col. 6 lines 22-25).
Regarding claim 22, Khalaj discloses a movable cover configured to cover at least a section of the window (FIG. 1, cover member 16 movable by hinge line 22).
Regarding claim 24, Khalaj discloses a catheter system (FIG. 5, securement device assembly 50) for medical applications, wherein the catheter system comprises:
a catheter tube configured to be inserted into an exit point in a patient's skin (catheter 32); and
a fixation device (catheter securement device 10) according to claim 1.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claim 3 above, and further in view of Hartman (United States Patent No. US 3,110,304 A).
Regarding claim 4, Khalaj in view of Panotopoulos does not disclose the body is configured to form a lead-in to the slit to facilitate insertion of the catheter tube into the channel in use. However, Hartman teaches the body is configured to form a lead-in to the slit to facilitate insertion of the catheter tube into the channel in use (FIG. 1, the shape of speculum 10 is the same as the claimed lead-in). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the edges of the opening of the Khalaj device with the funnel-like shape of the speculum taught by Hartman, which would allow for the catheter to have guided entry and exit from the incision site. Albeit a wider representation of the curved edge into a channel, the speculum functions in the same funneling manner as the intended lead-in.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claim 1 above, and further in view of Khalaj (United States Patent Application Publication No. US 2015/0088075 A1; herein, Khalaj 2).
Regarding claim 8, Khalaj in view of Panotopoulos does not disclose the sidewall is configured to form an overhang, wherein an end of the channel is provided in the overhang and wherein, when in use, the overhang spaces the second portion of the catheter tube from a proximal region of the sidewall. However, Khalaj 2 teaches the sidewall is configured to form an overhang, wherein an end of the channel is provided in the overhang and wherein, when in use, the overhang spaces the second portion of the catheter tube from a proximal region of the sidewall (FIG. 11B, transition 102 into catheter opening 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the edges of the opening of the Khalaj device with the rounded transitional opening taught by Khalaj 2 in order to provide a smooth transition that prevents kinking or pinching of the catheter during entry or exit of the placement site.
Claims 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claim 1 above, and further in view of Ekfeldt et al. (United States Patent Application No. US 2018/0325718 A1; herein, Ekfeldt).
Regarding claim 9, Khalaj in view of Panotopoulos does not disclose the first opening in the proximal surface is smaller than the second opening in the distal surface. However, Ekfeldt teaches the first opening in the proximal surface is smaller than the second opening in the distal surface (Fig. 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the openings of the Khalaj device with the structure of the Ekfeldt device, specifically the proximal surface hole being smaller than the distal, in order that any catheter or tubes used in tandem with the securement device can be held in place by the smaller proximal hole, while also allowing for visualization of the insertion site from the larger distal hole.
Regarding claim 16, Khalaj in view of Panotopoulos does not disclose the body is configured such that, when viewed from a side in a direction substantially parallel to the proximal surface, the distal surface has a substantially convex- shaped envelope. However, Ekfeldt teaches the body is configured such that, when viewed from a side in a direction substantially parallel to the proximal surface, the distal surface has a substantially convex- shaped envelope (Fig. 4 and Fig. 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter securement device, perhaps more specifically the housing of said device disclosed by Khalaj with the convex shape of the device taught by Ekfeldt in order to reduce the risk of catheter snagging by maintaining a fluid shape resulting in the device having a low-profile.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claim 1 above, and further in view of Hanson et al. (United States Patent Application Publication No. US 2016/0193452 A1; herein, Hanson).
Regarding claim 12, Khalaj in view of Panotopoulos does not disclose the body is configured to form a gap such that the second portion of the catheter tube can pass through the gap and into the through-hole when attaching the fixation device to the catheter tube in situ, wherein the gap extends from an end of the body to the side wall. However, Hanson teaches the body is configured to form a gap such that the second portion of the catheter tube can pass through the gap and into the through-hole (Fig. 2 and Fig. 5, recess (or slit or notch) 156) when attaching the fixation device to the catheter tube in situ, wherein the gap extends from an end of the body to the side wall (Fig. 2, recess 156 to central portion 154). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter securement device of Khalaj to include the recess as taught by Hanson in order to provide additional securement for the catheter.
Regarding claim 13, Khalaj in view of Panotopoulos does not disclose the width of the gap is substantially equal to or less than the diameter of the catheter tube. However, Hanson teaches the width of the gap is substantially equal to or less than the diameter of the catheter tube (Fig. 1 and Fig. 2, [0054] the recess 156 is configured to allow a portion of a catheter to pass through). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter securement device of Khalaj to include a recess having an equal or smaller width than that of the catheter as seen in Hanson in order to provide enough pressure against the outsides of the catheter so that the tube will not experience any unnecessary movements when secured.
Regarding claim 14, Khalaj in view of Panotopoulos does not disclose the body is configured to be able to deform to an extent sufficient for a user to manually open the gap to pass the second portion of the catheter tube through the gap. However, Hanson teaches the body is configured to be able to deform to an extent sufficient for a user to manually open the gap to pass the second portion of the catheter tube through the gap ([0054], The recess 156 allows a portion of the catheter to pass through, but it also allows the dressing body 102 as a whole to conform around bulky parts of medical articles. Therefore, by broadest reasonable interpretation, there would need to be some ability of the device to deform to fit around or with various medical articles.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter securement device of Khalaj in include a recess having deformative properties as seen in Hanson in order that various sized catheters may be able to fit and be secured within the recess.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claim 18 above, and further in view of Bierman (United States Patent Application Publication No. US 2002/0133121 A1).
Regarding claim 19, Khalaj in view of Panotopoulos does not disclose the body comprises a channel portion which is common to the first channel and to the second channel. However, Bierman teaches the body comprises a channel portion which is common to the first channel and to the second channel (Fig. 9 and Fig. 10, S-clip 124 allows for catheter portions to exist in multiple channels at once). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interior space and slots of Khalaj to allow for catheter portions to be secured in multiple channels as seen in the S-clip taught by Bierman in order to give more directional freedom of the catheter to users. The device disclosed by Khalaj already allows for the catheter to exit from multiple slot options, but only one at a time. The modification would give the option for the catheter to sit in more than one slot at a given moment.
Claim(s) 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khalaj in view of Panotopoulos as applied to claims 18 and 1 above, and further in view of Her (United States Patent Application Publication No. US 2018/0236206 A1).
Regarding claim 20, Khalaj in view of Panotopoulos does not disclose the body is configured such that, when viewed in cross-section from a side in a direction substantially perpendicular to the proximal surface, the second channel comprises one or more curved regions which bend a third portion of the catheter tube. However, Her teaches the body is configured such that, when viewed in cross-section from a side in a direction substantially perpendicular to the proximal surface, the second channel comprises one or more curved regions which bend a third portion of the catheter tube (FIG. 6a, second guide hole GH2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slots of Khalaj to incorporate a curved portion as taught by Her in order for a more fluid bend of the catheter to occur when going from one channel to the next. This would reduce the chances of kinking within the catheter as well.
Regarding claim 21, Khalaj in view of Panotopoulos does not disclose the body is configured such that, when viewed in cross-section from a side in a direction substantially parallel to the proximal surface, the channel comprises one or more curved regions which bend the first portion of the catheter. However, Her teaches the body is configured such that, when viewed in cross-section from a side in a direction substantially parallel to the proximal surface, the channel comprises one or more curved regions which bend the first portion of the catheter (FIG. 6a and FIG. 8, second guide hole GH2 holds all portions of the catheter at some point). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slots of Khalaj to incorporate a curved portion as taught by Her in order for a more fluid bend of the catheter to occur when going from one channel to the next. This would reduce the chances of kinking within the catheter as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/ Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783