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 11/19/2025 has been entered. Claims 10-15, 17-19, 21-22, 24-32 are pending in the application. Applicant' s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 07/23/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first portion” and “second portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitations “first portion” and “second portion” of the catheter dressing lack proper antecedent basis in the specification.
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.
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.
Claims 10-11, 15, 17-19, 21-22, 24, 29, 30, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dabel (US 2022/0379092) in view of Zhang (CN 203790420). * Citations to Zhang are directed to the translated description attached
Regarding Claim 10, Dabel discloses a method of securing a catheter (22, Fig 7) to a patient, the method comprising: securing a catheter dressing (11, Fig 2) to skin of the patient so that the catheter dressing completely encloses an exterior portion of the catheter that extends out of the patient (Para 0021); after securing the catheter dressing to the skin of the patient, securing a catheter hub of the catheter and a portion the catheter dressing within a securement device (52 and 54, Fig 2); securing the securement device to the skin of the patient; and moving a retaining strap (54, Fig 2) of the securement device that includes a first connector (“adhesive”) to a closed position so that the first connector that includes a self-gripping material engages a second portion of the catheter dressing to resist movement of the catheter dressing relative to the securement device (Para 0020).
Dabel is silent regarding inserting a catheter hub of the catheter and a portion the catheter dressing within a recess of the securement device while a second portion of the catheter dressing extends outwardly from a top surface that defines the recess.
Zhang teaches inserting a catheter hub (10, Fig 1) of the catheter within a recess (41, Fig 3) of the securement device (100, Fig 4) and moving a retaining strap (50, Fig 3) of the securement device that includes a first connector (“hooks”) to a closed position (“the catheter fixing wing 10 is first placed in the opening groove 41 in the middle of the foam layer 40, and then the cover sheet 50 is covered, and the cover sheet 50 and the bottom adhesive sheet 10 are pasted by the adhesive tape.”; Page 2, Paragraph 9).
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 securement device disclosed by Dabel to be the securement device comprising the recess taught by Zhang in order to have a securement device that can better restrict movement of the catheter to reduce patient suffering and the burden of care (“When the fixing device is used, the catheter fixing wing is first placed in the opening groove in the middle of the foam layer, and then the cover sheet is covered, and the cover sheet and the bottom adhesive sheet are pasted by the fastening button, so that the catheter fixing wing is restricted In the opening groove of the foam layer, the catheter is further fixed. Therefore, the utility model can effectively fix the catheter and reduce the suffering of the patient and the burden of care.”; Page 2, Paragraph 1).
Examiner notes that the combined invention of Dabel and Zhang would have both the catheter hub and a first portion of the catheter dressing secured within the recess of the securement device of Zhang since the catheter dressing completely surrounds the catheter hub similar to what is shown in Fig 7 of Dabel. Further, the combined invention would necessarily have a second portion (a top surface) of the catheter dressing extends outwardly from a top surface that defines the recess as Figs 1 and 7 of Dabel shows that the catheter dressing 16 is wider, deeper, and longer than the catheter 22. Therefore, some of the dressing will extend outward from the recess that is adapted to fit the catheter (Page 2, Paragraph 9 -Zhang).
Regarding Claim 11, the modified invention of Dabel and Zhang discloses directly contacting the self-gripping material against the second portion of the catheter dressing at an interface portion, wherein the interface portion has no adhesive element so the catheter dressing does not get stuck or damaged (See Fig 7; Para 0020 -Dabel; “The cover sheet 50 is provided with a raised portion 51, and the bottom adhesive sheet 30 is provided with a hook portion 31 at a position corresponding to the raised portion 51, and the hook portion 31 of the bottom adhesive sheet 30 has a plurality of ejection hooks. The raised portion 51 and the hook portion 31 form a hook to form a sticker between the cover sheet 50 and the bottom adhesive sheet 30.”, Page 2, Paragraph 11 -Zhang; Dabel teaches that the self-gripping material interfaces with a tab that is on the sleeve so that there is no adhesive contacting the dressing to damage it. Additionally, Zhang teaches using hook and loop arrangement as the self-gripping material to secure the strap and thus no adhesive can stick to or damage the dressing).
Regarding Claim 15, the modified invention of Dabel and Zhang discloses the act of securing the catheter dressing to the skin of the patient further comprises adhering an adhesive structure (12, Fig 4 -Dabel) of the catheter dressing to the skin of the patient so that the catheter dressing completely encloses the exterior portion of the catheter that extends out of the patient to ensure the catheter dressing is water-resistant (Para 0021; See Fig 7 -Dabel).
Regarding Claim 17, the modified invention of Dabel and Zhang discloses the act of securing the securement device further comprises adhering a rear surface of the securement device to form a second connection point to the skin of the patient that is spaced apart from a rim of the catheter dressing that forms a first connection point to the skin of the patient (Para 0021 -Dabel), the act of moving the retaining strap (50, Fig 3 -Zhang) that includes the first connector to the closed position stops catheter migration or inadvertent removal by the securement device providing the second connection point to the skin the patient (“the catheter fixing wing 10 is first placed in the opening groove 41 in the middle of the foam layer 40, and then the cover sheet 50 is covered, and the cover sheet 50 and the bottom adhesive sheet 10 are pasted by the adhesive tape.”; Page 2, Paragraph 9 -Zhang).
Regarding Claim 18, the modified invention of Dabel and Zhang discloses the securement device includes an anchoring body (40, Fig 3 -Zhang) that includes the top surface that defines the recess (41, Fig 3 -Zhang), a first wing portion (portion of sheet 30 to the right of the anchoring body, Fig 3 -Zhang), and a second wing portion (portion of sheet 30 to the left of the anchoring body, Fig 3 -Zhang), wherein the act of moving the retaining strap (50, Fig 3 -Zhang) that includes the first connector to the closed position further comprises moving the first connector of the retaining strap from the first wing portion to the second wing portion to cover the top surface (See Figs 4-5 -Zhang).
Regarding Claim 19, the modified invention of Dabel and Zhang discloses securing the first connector to each of the second wing portion, and the second portion of the catheter dressing (Para 0021 -Dabel; Page 2, Paragraph 11 -Zhang; closing the strap around the catheter dressing and anchoring body with the hook and loop connectors secures the first connector at least indirectly to all of those elements).
Regarding Claim 21, the modified invention of Dabel and Zhang discloses the act of inserting the catheter hub and the first portion the catheter dressing within the recess of the securement device while the second portion of the catheter dressing extends outwardly from the top surface that defines the recess resists movement or reduces irritation of an insertion site of the catheter caused by stresses and forces applied on fittings connected to the catheter (“When the fixing device is used, the catheter fixing wing is first placed in the opening groove in the middle of the foam layer, and then the cover sheet is covered, and the cover sheet and the bottom adhesive sheet are pasted by the fastening button, so that the catheter fixing wing is restricted In the opening groove of the foam layer, the catheter is further fixed. Therefore, the utility model can effectively fix the catheter and reduce the suffering of the patient and the burden of care.”; Page 2, Paragraph 1 -Zhang).
Regarding Claim 22, the modified invention of Dabel and Zhang discloses preventing any portion of the securement device from directly contacting the catheter by completely surrounding the exterior portion of the catheter within the catheter dressing (Para 0021 -Dabel).
Regarding Claim 24, the modified invention of Dabel and Zhang discloses the act of moving the retaining strap that includes the first connector to the closed position further comprises pivoting the retaining strap so that the first connector covers the cushioned impression formed by the recess and extends past a cushioned impression to removably attach to a second connector of a second wing portion (“The cover sheet 50 is provided with a raised portion 51, and the bottom adhesive sheet 30 is provided with a hook portion 31 at a position corresponding to the raised portion 51, and the hook portion 31 of the bottom adhesive sheet 30 has a plurality of ejection hooks. The raised portion 51 and the hook portion 31 form a hook to form a sticker between the cover sheet 50 and the bottom adhesive sheet 30.”; Page 2, Paragraph 11 -Zhang).
Regarding Claim 29, Dabel teaches a system for securing a catheter that includes a catheter hub to a patient, the system comprising:(a) a catheter dressing (10, Fig 2) configured to completely enclose an exterior portion of the catheter that extends out of the patient (Para 0021; See Fig 7), wherein the catheter dressing includes an exterior surface (16, Fig 2); and(b) a securement device (52 and 54, Fig 2) comprising a retaining strap (54, Fig 2) that includes a first connector (“adhesive, wherein in the closed position, the first connector includes a non- adhesive self-gripping material is configured to engage the exterior surface of the catheter dressing to resist movement of the catheter dressing relative to the securement device”) (Para 0020).
Dabel is silent regarding the securement device completely separable from the catheter dressing, the securement device and comprising:(i) an anchoring body configured to be attached to the patient, wherein the anchoring body defines a recess configured to receive the catheter hub that is completely enclosed within the catheter dressing,(ii) first and second wing portions extending away from the anchoring body in opposite directions, and (iii) a retaining strap that includes a first connector, wherein the retaining strap is connected to one of the first and second wing portions so as to be movable between an open position and a closed position ,wherein in the open position, the catheter hub and a portion of the catheter dressing is configured to be received within the recess, wherein in the closed position, the first connector includes a non- adhesive self-gripping material is configured to engage a second portion of the catheter dressing to resist movement of the catheter dressing relative to the securement device.
Zhang teaches a securement device completely separable from the catheter, the securement device capable of securing a catheter hub (10, Fig 1) wherein the securement device comprises: : (i) an anchoring body (40, Fig 3) configured to be attached to the patient, wherein the anchoring body defines a recess (41, Fig 3) configured to receive the catheter hub,(ii) first (portion of sheet 30 to the right of the anchoring body, Fig 3) and second (portion of sheet 30 to the left of the anchoring body, Fig 3) wing portions extending away from the anchoring body in opposite directions (See Fig 3), and (iii) a retaining strap (50, Fig 3) that includes a first connector (“hooks”), wherein the retaining strap is connected to one of the first and second wing portions so as to be movable between an open position and a closed position ,wherein in the open position, the catheter hub is configured to be received within the recess, wherein in the closed position, the first connector includes a non-adhesive self-gripping material is configured to engage the exterior surface to resist movement of the catheter dressing relative to the securement device (“the catheter fixing wing 10 is first placed in the opening groove 41 in the middle of the foam layer 40, and then the cover sheet 50 is covered, and the cover sheet 50 and the bottom adhesive sheet 10 are pasted by the adhesive tape.”; Page 2, Paragraph 9; See Figs 4-5).
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 securement device disclosed by Dabel to be the securement device comprising the recess taught by Zhang in order to have a securement device that can better restrict movement of the catheter to reduce patient suffering and the burden of care (“When the fixing device is used, the catheter fixing wing is first placed in the opening groove in the middle of the foam layer, and then the cover sheet is covered, and the cover sheet and the bottom adhesive sheet are pasted by the fastening button, so that the catheter fixing wing is restricted In the opening groove of the foam layer, the catheter is further fixed. Therefore, the utility model can effectively fix the catheter and reduce the suffering of the patient and the burden of care.”; Page 2, Paragraph 1).
Examiner notes that the combined invention of Dabel and Zhang would have both the catheter hub and a first portion of the catheter dressing secured within the recess of the securement device of Zhang since the catheter dressing completely surrounds the catheter hub similar to what is shown in Fig 7 of Dabel. Further, the combined invention would necessarily have a second portion (a top surface) of the catheter dressing extends outwardly from a top surface that defines the recess as Figs 1 and 7 of Dabel shows that the catheter dressing 16 is wider, deeper, and longer than the catheter 22. Therefore, some of the dressing will extend outward from the recess that is adapted to fit the catheter (Page 2, Paragraph 9 -Zhang).
Regarding Claim 30, the modified invention of Dabel and Zhang discloses the act of moving the retaining strap further comprises moving the retaining strap of the securement device that includes the first connector to the closed position so that the first connector that includes the self-gripping material directly engages the second portion of the catheter dressing to resist movement of the catheter dressing relative to the securement device (“The cover sheet 50 is provided with a raised portion 51, and the bottom adhesive sheet 30 is provided with a hook portion 31 at a position corresponding to the raised portion 51, and the hook portion 31 of the bottom adhesive sheet 30 has a plurality of ejection hooks. The raised portion 51 and the hook portion 31 form a hook to form a sticker between the cover sheet 50 and the bottom adhesive sheet 30.”; Page 2, Paragraph 11 -Zhang).
Regarding Claim 32, the modified invention of Dabel and Zhang discloses in the open position, the catheter hub and the first portion of the catheter dressing are configured to be received within the recess and second portion of the catheter dressing is configured to simultaneously extend along the top surface that defines the recess, and wherein in the closed position, the non-adhesive self-gripping material of the first connector is configured to directly engage the second portion of the catheter dressing to resist movement of the catheter dressing relative to the securement device (Para 0020 -Dabel; Page 2, Paragraphs 9-11 -Zhang; the combined invention would necessarily have a second portion (a top surface) of the catheter dressing that extends along the top surface that defines the recess as Figs 1 and 7 of Dabel shows that the catheter dressing 16 is wider, deeper, and longer than the catheter 22. Therefore, some of the dressing will extend outward from the recess that is adapted to fit the catheter ).
Claims 12-14, 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Dabel (US 2022/0379092) in view of Zhang (CN 203790420) and further in view of Bierman (US 6,428,516).
Regarding Claim 12, the modified invention of Dabel and Zhang discloses all of the elements of the invention as discussed above, however, is silent regarding the act of inserting the securement device to the skin of the patient is performed after the act of securing the catheter hub of the catheter and the first portion the catheter dressing within the recess of the securement device while the second portion of the catheter dressing extends outwardly from the top surface that defines the recess.
Bierman teaches that the act of securing the securement device (32c, Fig 5) to the skin of the patient is performed after the act of securing the catheter hub (12c, Fig 5) of the catheter within the recess (50, Fig 5) of the securement device (Col 8, lines 35-48).
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 method to have the securement device secured to the skin after the catheter hub is secured in the securement device as Bierman teaches that these steps can be carried out in any order and would have the same result (Col 8, lines 35-48).
Regarding Claim 13, the modified invention of Dabel and Zhang discloses all of the elements of the invention as discussed above, however, is silent regarding the act of inserting the securement device to the skin of the patient is performed before the act of securing the catheter hub of the catheter and the portion the catheter dressing within the recess of the securement device while the second portion of the catheter dressing extends outwardly from the top surface that defines the recess.
Bierman teaches that the act of securing the securement device (32c, Fig 5) to the skin of the patient is performed before the act of securing the catheter hub (12c, Fig 5) of the catheter within the recess (50, Fig 5) of the securement device (Col 8, lines 35-48).
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 method to have the securement device secured to the skin before the catheter hub is secured in the securement device as Bierman teaches that these steps can be carried out in any order and would have the same result (Col 8, lines 35-48).
Regarding Claim 14, the modified invention of Dabel and Zhang discloses the act of securing the securement device to the skin of the patient is performed after the act of securing the catheter dressing to the skin of the patient (Para 0021 -Dabel), however, is silent regarding the act of moving the retaining strap that includes the first connector to the closed position is performed after the act of securing the securement device to the skin of the patient.
Bierman teaches that the act of securing the securement device (32c, Fig 5) to the skin of the patient is performed before the act of securing the catheter to the securement device (Col 8, lines 35-48).
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 method to have the securement device secured to the skin before the catheter is secured in the securement device (via the retaining strap) as Bierman teaches that these steps can be carried out in any order and would have the same result (Col 8, lines 35-48).
Regarding Claim 26, Dabel discloses method of securing a catheter (22, Fig 7) to a patient, the method comprising: securing a catheter dressing (16, Fig 2) to skin of the patient so that the catheter dressing completely encloses an exterior portion of the catheter that extends out of the patient (Para 0021); after securing the catheter dressing to the skin of the patient, securing a securement device (52 and 54, Fig 2) to the skin of the patient (Para 0020-0021); moving a retaining strap (54, Fig 2) of the securement device that includes a first connector (“adhesive”) to a closed position so that the first connector that includes a self-gripping material engages an exterior surface of the catheter dressing to resist movement of the catheter dressing relative to the securement device (Para 0020).
Dabel is silent regarding after securing the securement device to the skin of the patient, inserting a catheter hub of the catheter and a first portion the catheter dressing within a recess of the securement device while a second portion of the catheter dressing extends outwardly from a top surface that defines the recess; and after securing the catheter hub of the catheter and the portion the catheter dressing within the recess of the securement device
Zhang teaches a securement device capable of securing a catheter hub (10, Fig 1) of the catheter within a recess (41, Fig 3) of the securement device and moving a retaining strap (50, Fig 3) of the securement device that includes a first connector (“adhesive”) to a closed position (“the catheter fixing wing 10 is first placed in the opening groove 41 in the middle of the foam layer 40, and then the cover sheet 50 is covered, and the cover sheet 50 and the bottom adhesive sheet 10 are pasted by the adhesive tape.”; Page 2, Paragraph 9).
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 securement device disclosed by Dabel to be the securement device comprising the recess taught by Zhang in order to have a securement device that can better restrict movement of the catheter to reduce patient suffering and the burden of care (“When the fixing device is used, the catheter fixing wing is first placed in the opening groove in the middle of the foam layer, and then the cover sheet is covered, and the cover sheet and the bottom adhesive sheet are pasted by the fastening button, so that the catheter fixing wing is restricted In the opening groove of the foam layer, the catheter is further fixed. Therefore, the utility model can effectively fix the catheter and reduce the suffering of the patient and the burden of care.”; Page 2, Paragraph 1).
Examiner notes that the combined invention of Dabel and Zhang would have both the catheter hub and a first portion of the catheter dressing secured within the recess of the securement device of Zhang since the catheter dressing completely surrounds the catheter hub similar to what is shown in Fig 7 of Dabel. Further, the combined invention would necessarily have a second portion (a top surface) of the catheter dressing extends outwardly from a top surface that defines the recess as Figs 1 and 7 of Dabel shows that the catheter dressing 16 is wider, deeper, and longer than the catheter 22. Therefore, some of the dressing will extend outward from the recess that is adapted to fit the catheter (Page 2, Paragraph 9 -Zhang).
The modified invention of Dabel and Zhang discloses all of the elements of the invention as discussed above, however, is silent regarding the act of securing the catheter hub of the catheter and the portion the catheter dressing within the recess of the securement device is performed after the act of securing the securement device to the skin of the patient.
Bierman teaches that the act of securing the catheter hub (12c, Fig 5) of the catheter within the recess (50, Fig 5) of the securement device (32c, Fig 5) is performed after the act of securing the securement device to the skin of the patient (Col 8, lines 35-48).
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 method to have the securement device secured to the skin before the catheter hub is secured in the securement device as Bierman teaches that these steps can be carried out in any order and would have the same result (Col 8, lines 35-48).
Regarding Claim 27, the modified invention of Dabel, Zhang, and Bierman discloses engaging the self-gripping material against at least the second portion of the catheter dressing at an interface portion, wherein the interface portion has no adhesive element so the catheter dressing does not get stuck or damaged (Para 0020 -Dabel; “The cover sheet 50 is provided with a raised portion 51, and the bottom adhesive sheet 30 is provided with a hook portion 31 at a position corresponding to the raised portion 51, and the hook portion 31 of the bottom adhesive sheet 30 has a plurality of ejection hooks. The raised portion 51 and the hook portion 31 form a hook to form a sticker between the cover sheet 50 and the bottom adhesive sheet 30.”; Page 2, Paragraph 11 -Zhang; Dabel teaches that the self-gripping material interfaces with a tab that is on the sleeve so that there is no adhesive contacting the dressing to damage it. Additionally, Zhang teaches using hook and loop arrangement as the self-gripping material to secure the strap and thus no adhesive can stick to or damage the dressing).
Regarding Claim 28, the modified invention of Dabel, Zhang, and Bierman discloses the self-gripping material is a non- adhesive self-gripping material that engages the exterior surface of the catheter dressing to resist movement of the catheter dressing relative to the securement device (Para 0020 -Dabel; “The cover sheet 50 is provided with a raised portion 51, and the bottom adhesive sheet 30 is provided with a hook portion 31 at a position corresponding to the raised portion 51, and the hook portion 31 of the bottom adhesive sheet 30 has a plurality of ejection hooks. The raised portion 51 and the hook portion 31 form a hook to form a sticker between the cover sheet 50 and the bottom adhesive sheet 30.”; Page 2, Paragraph 11 -Zhang; Dabel teaches that the self-gripping material interfaces with a tab that is on the sleeve so that there is no adhesive contacting the dressing to damage it. Additionally, Zhang teaches using hook and loop arrangement as the self-gripping material to secure the strap and thus no adhesive can stick to or damage the dressing).
Claims 25 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Dabel (US 2022/0379092) in view of Zhang (CN 203790420) and further in view of Kyvik (US 2008/0200880).
Regarding Claim 25, the modified invention of Dabel and Zhang discloses the securement device (100, Fig 3 -Zhang) includes an anchoring body (40, Fig 3 -Zhang), where in the anchoring body includes a top surface that defines the cushioned impression (See Fig 3 -Zhang), wherein an elevation of the cushioned impression is defined by a distance between the top surface and a bottom surface (See Fig 4 -Zhang), however, it is unclear if Zhang teaches the elevation is a distance that is greater than or equal to a thickness of the catheter hub.
Kyvik teaches an analogous securement device (10, Fig 1) including an anchoring body (14, Fig 2), where in the anchoring body includes a top surface that defines a shape the cushioned impression, wherein an elevation of the cushioned impression is defined by a distance between the top surface and a bottom surface, wherein the elevation is a distance that is greater than or equal to a thickness of the catheter hub (Para 0017).
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 anchoring body to have an elevation with a distance that is greater than or equal to a thickness of the catheter hub as taught by Kyvik in order to have a securement device that improves security by restricting movement in all directions (Para 0004).
Regarding Claim 31, modified invention of Dabel and Zhang discloses all of the elements of the invention as discussed above, however is silent regarding moving the retaining strap of the securement device to the open position; and completely separating the catheter dressing from the securement device.
Kyvik teaches an analogous securement device (10, Fig 1) and a method step of moving the retaining strap of the securement device to the open position; and completely separating the catheter from the securement device (Para 0017).
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 method to include moving the retaining strap of the securement device to the open position; and completely separating the catheter and catheter dressing from the securement device in order to easily inspect or remove the catheter and catheter dressing from the securement device (Para 0017).
Response to Arguments
Applicant’s arguments filed 11/19/2025, on pages 9-10, regarding Dabel and Zhang failing to teach the amended limitations have been fully considered but are not persuasive. After further consideration, it appears that Dabel and Zhang do still read on the claimed invention. The new limitation, “while a second portion of the catheter dressing extends outwardly from a top surface that defines the recess” is a structural limitation and does not actually change the method step of inserting a catheter hub. It simply requires the catheter dressing to be dimensioned such that it is larger than the recess. As detailed in the rejection above, Figs 1 and 7 of Dabel shows that the catheter dressing 16 is wider, deeper, and longer than the catheter 22. Therefore, some of the dressing will necessarily extend outward from the recess that is adapted to fit the catheter (Page 2, Paragraph 9 -Zhang).
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785