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 02/03/2026 has been entered. Claims 1-2, 4-27 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 10/01/2025.
Claim Rejections - 35 USC § 102
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.
Claims 23, 24, 26, 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wright ‘482 (US 2010/0179482).
Regarding Claim 23, Wright ‘482 discloses an apparatus for removably securing a catheter to a patient (Para 0143), the apparatus comprising: a flexible structure having a top surface and a bottom surface (“adhesive pad”, Para 0152); and a securement structure (630, Fig 67) coupled to the top surface of the flexible structure, the securement structure configured to receive the medical device, the securement structure comprising: a base (631, Fig 67); a first receiving sleeve (one of clamps 641, Fig 67) fixedly coupled to the base (Para 0141-0142, only one of the clamps can be moveable in order to operate the device while the other can be locked in places by the ribs); and a second receiving sleeve (other one of clamps 641, Fig 67) opposed from the first receiving sleeve and movably coupled to the base (Para 0143), the second receiving sleeve being movable along a first axis that is perpendicular to a second axis defined by the catheter and within a plane parallel to the flexible structure (Para 0143).
Regarding Claim 24, Wright ‘482 discloses the second receiving sleeve is movably coupled to the base with a sliding track (633, Fig 67, Para 0143).
Regarding Claim 26, Wright ‘482 discloses the second receiving sleeve (other one of clamps 641, Fig 67) is movable between at least a first position and a second position, and wherein in the first position the second receiving sleeve is spaced a distance from the first receiving sleeve that is greater than a width of the medical device (Para 0143, See Fig 67).
Regarding Claim 27, Wright ‘482 discloses a pull tab (637, Fig 65) coupled to the second receiving sleeve (Para 0142).
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.
Claims 1, 4-14, 18, 19, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US 2011/0288487) in view of Bierman (US 5,456,671).
Regarding Claim 1, Wright discloses an apparatus (20, 162, Fig 2) for removably securing a medical device to a patient, the apparatus comprising: a flexible structure (162, Fig 2) having a top surface and a bottom surface; and a securement structure (20, Fig 2) coupled to the top surface of the flexible structure (Para 0067), the securement structure configured to receive the medical device (Para 0051), the securement structure comprising: a base (26, Fig 1); and a cover (28, Fig 1) movably coupled to the base, wherein the cover is configured to move between at least a first position and a second position (Para 0057), wherein the cover and the base are engaged with the medical device when the cover is in the second position (Para 0061).
While Wright discloses an orientation indicator (49, Fig 3) defined on securement structure (Para 0052), it is silent regarding an orientation indicator defined on the top surface of the flexible structure and visible from above when the cover is in the second position.
Bierman teaches an analogous apparatus comprising a securement structure (20, Fig 2) coupled to a top surface of a flexible structure (16, Fig 2) and further comprising an orientation indicator (70, Fig 2) defined on the top surface of the flexible structure and visible from above even when the securement structure is covered (Col 10, lines 20-29).
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 orientation indicator disclosed by Write to be located on the top surface of the flexible structure as taught by Bierman in order to aid the provider in correctly positioning the apparatus even when the medical device is obstructing the securement structure (Col 13, line 58- Col 14, lines 18).
Regarding Claim 4, the modified invention of Wright and Bierman discloses the bottom surface comprises an adhesive (Para 0067 -Wright).
Regarding Claim 5, the modified invention of Wright and Bierman discloses the securement structure (20, Fig 2 -Wright) is a clamp (Para 0061; See Fig 9 -Wright).
Regarding Claim 6, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) comprises at least one engagement portion (45, Fig 2 -Wright) configured to align with the medical device (Para 0060 -Wright).
Regarding Claim 7, the modified invention of Wright and Bierman discloses the engagement portion (45, Fig 2 -Wright) is one or more of a recessed portion (Para 0052), a base alignment structure, a top alignment structure (Para 0060 -Wright), a stabilizing structure, a clip, a wing recess, and a foam pad
Regarding Claim 8, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) defines at least one recessed portion (45, Fig 2 -Wright) configured to nest with the medical device (Para 0060 -Wright).
Regarding Claim 9, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) defines at least one wing recess (recess formed by walls 41 and 46, Fig 4 -Wright) configured to nest with a wing of the medical device (Para 0052 -Wright).
Regarding Claim 10, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) defines at least one ledge (41, Fig 4 -Wright)
Regarding Claim 11, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) comprises at least one base alignment structure (47, Fig 3 -Wright) (Para 0060 -Wright).
Regarding Claim 12, the modified invention of Wright and Bierman discloses the base alignment structure (47, Fig 3 -Wright) is a pin (Para 0060 -Wright).
Regarding Claim 13, the modified invention of Wright and Bierman discloses the cover (28, Fig 1 -Wright) is hingedly coupled to the base (Para 0057 -Wright).
Regarding Claim 14, the modified invention of Wright and Bierman discloses the cover (28, Fig 1 -Wright) is pivotally coupled to the base (Para 0057 -Wright).
Regarding Claim 18, the modified invention of Wright and Bierman discloses the cover (28, Fig 1 -Wright) comprises at least one top alignment structure (82, Fig 7 -Wright) (Para 0059 -Wright).
Regarding Claim 19, the modified invention of Wright and Bierman discloses the cover (28, Fig 1 -Wright) comprises a stabilizing structure (82, Fig 7 -Wright) (Para 0059 -Wright).
Regarding Claim 21, the modified invention of Wright and Bierman discloses the base (26, Fig 1 -Wright) comprises a flanged portion (52, Fig 1 -Wright); and the cover (28, Fig 1 -Wright) comprises a lip portion (80, Fig 1 -Wright) configured to removably lock with the flanged portion (Para 0061, Para 0066 -Wright).
Regarding Claim 22, the modified invention of Wright and Bierman discloses the cover (28, Fig 1 -Wright) is in the second position, the flanged portion and the lip portion snap together to form a clamp (Para 0061 -Wright).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US 2011/0288487) in view of Bierman (US 5,456,671) and further in view of Kight (US 2018/0256853).
Regarding Claim 2, the modified invention of Wright and Bierman discloses all of the elements of the invention as discussed above, however, is silent regarding a peel tab defined by the flexible structure.
Kight teaches an analogous flexible structure (101, Fig 1) with an adhesive on the bottom surface, wherein a peel tab (102, Fig 1) is defined by the flexible structure (Para 0039).
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 flexible structure to include a peel tab as taught by Kight in order to facilitate peeling the adhesive pad off of a surface (Para 0039).
Claims 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US 2011/0288487) in view of Bierman (US 5,456,671) and further in view of Pickering (US 2021/0370025).
Regarding Claim 15, the modified invention of Wright and Bierman discloses all of the elements of the invention as discussed above, however, is silent regarding the base comprises a foam pad and the cover comprises a second foam pad.
Pickering teaches an analogous apparatus wherein the base (12, Fig 5) comprises a foam pad (12b, Fig 5) and the cover (22, Fig 5) comprises a second foam pad (22a, Fig 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 cover and base to include each include a foam pad as taught by Wright in order to increase frictional forces to prevent sliding of the medical device (Para 0051).
Regarding Claim 17, the modified invention of Wright, Bierman and Pickering discloses one or more of the foam pad (12b, Fig 5 -Wright) and the second foam pad (22a, Fig 5 -Wright) defines a recessed portion (See Fig 5 -Wright).
Claims 16, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US 2011/0288487) in view of Bierman (US 5,456,671) and further in view of Pickering (US 2021/0370025) and further in view of Edds (US 2022/0016336).
Regarding Claim 16, the modified invention of Wright, Bierman and Pickering discloses all of the elements of the invention as discussed above, however, is silent regarding one or more of the foam pad and the second foam pad is memory foam.
Edd teaches an analogous apparatus comprising herein the base comprises a foam pad (201, Fig 15) and the cover comprises a second foam pad (201, Fig 15); wherein one or more of the foam pad and the second foam pad is memory foam (Para 0101).
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 foam pads disclosed by Pickering to be memory foam in order to have a channel that can mold itself to different sized devices to improve security of the medical device in the apparatus (Para 0101).
Regarding Claim 20, the modified invention of Wright and Bierman discloses the stabilizing structure (82, Fig 7 -Wright), however is silent regarding it is a rubber gripper.
Edd teaches an analogous apparatus comprising a stabilizing structure that is a rubber gripper (“non-adhesive silicon rubber”, Para 0101).
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 stabilizing structure to be made of a non-adhesive silicon rubber as taught by Edd in order to increase the frictional forces to prevent sliding between components (Para 0101).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Pickering (US 2021/0370025) in view of Khalaj (US 2015/0088075).
Regarding Claim 23, Pickering an apparatus (310, Fig 9) for removably securing a medical device to a patient, the apparatus comprising: a securement structure (312, 313, 322, Fig 9), the securement structure configured to receive the medical device (50, Fig 9), the securement structure comprising: a base (312, Fig 9); a first receiving sleeve (313, Fig 9) fixedly coupled to the base (Para 0062); and a second receiving sleeve (322, Fig 9) opposed from the first receiving sleeve and movably coupled to the base (Para 00062), the second receiving sleeve being movable along a first axis that is perpendicular to a second axis defined by the catheter and within a plane parallel to the base (See annotated Fig 10B).
Pickering is silent regarding a flexible structure having a top surface and a bottom surface and a securement structure coupled to the top surface of the flexible structure
Khalaj teaches an apparatus (10, 200, Fig 13) for removably securing a medical device to a patient (Para 0001), the apparatus comprising: a flexible structure (200, Fig 13) having a top surface and a bottom surface; and a securement structure (10, Fig 13) coupled to the top surface of the flexible structure (Para 0046).
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 apparatus disclosed by Pickering to include an adhesive flexible structure as taught by Khalaj in order attach the device to the skin of a patient non-invasively (Para 0046). Khalaj also teaches that apertures (such as apertures 14 in Pickering) in the base can be used to secure the securement structure to a patient or to enhance connection between the securement structure and flexible structure (Para 0037).
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Regarding Claim 24, the modified invention of Pickering and Khalaj discloses the second receiving sleeve (322, Fig 9 -Pickering) is movably coupled to the base with a sliding track (Internal space of 313 couples and guides the second receiving sleeve, See Fig 10B).
Regarding Claim 25, the modified invention of Pickering and Khalaj discloses the sliding track is spring loaded (Spring 327, Fig 10B -Pickering) (Para 0063 -Pickering).
Response to Arguments
Applicant’s arguments regarding filed 02/03/2026, on pages 1-3, regarding Wright failing to teach the orientation indicator as claimed in amended claim 1 have been fully considered but are moot in view of the current rejection that relies on Bierman to teach the amended limitations.
Applicant’s arguments regarding filed 02/03/2026, on pages 3-5, regarding Khalaj failing to teach the that the second receiving sleeve is movable along a first axis that is perpendicular to a second axis have been fully considered but are moot in view of the current rejection that no longer relied on Khalaj to teach the first and second receiving sleeves. Khalaj is only relied on in the current rejection to teach an adhesive flexible structure.
Applicant’s arguments regarding filed 02/03/2026, on page 7, regarding Pickering failing to teach “the second receiving sleeve being movable along a first axis that is perpendicular to a second axis defined by the catheter and within a plane parallel to the flexible structure” have been fully considered but is not persuasive. As illustrated in the annotated Fig 10B below, the second receiving sleeve 322 moves along the first axis which is perpendicular to the second axis that is defined by catheter 54 and the second axis is within a plane that is parallel to the base (or flexible structure in the combination).
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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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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