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
This office action is responsive to the amendment filed on June 22, 2026. As directed by the amendment: claim 1 has been amended and claim 8 has been cancelled. Thus, claims 1-7 and 9-13 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed June 22, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to the prior art not teaching or disclosing the added limitation of claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found reference Sniffin.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 7, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6, 7, and 13, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “spherical” in the claims is used by the claim to mean “circular,” while the accepted meaning is “having the form of a sphere, which is a globular body.” The term is indefinite because the specification does not clearly redefine the term. A sphere is generally understood to mean a globe-like structure; however, the spherical portion (66 in the Drawings) is not a globe-like structure/portion.
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) 1-5, 9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sniffin (US 20160310225).
Regarding claim 1, Sniffin discloses a secondary securement device for a vascular access device (fig. 1A/B) comprising:
a base (receiving portion 10 in fig. 1A) including a first end, a second end positioned opposite the first end, a first side, a second side positioned opposite the first side, a top surface, and a bottom surface positioned opposite the top surface (see below), the bottom surface configured to be in contact with a patient's skin surface (the bottom surface designated below is capable of being in contact with skin);
PNG
media_image1.png
478
678
media_image1.png
Greyscale
a first securing member (retaining member 50 in fig. 1B, see below) including a first end connected to the base (end connected to receiving portion 10 in fig. 1B) and a second end positioned opposite from the first end (free end of the retaining member 50 in fig. 1B), the second end moveable relative to the base (paragraph 24 discloses the members being “transitioned into a deployed configuration”), the first securing member defining a first opening configured to receive a first portion of the vascular access device (see below);
a second securing member (retaining member 50 in fig. 1B, see below) including a first end connected to the base (end connected to receiving portion 10 in fig. 1B) and a second end positioned opposite from the first end (free end of the retaining member 50 in fig. 1B), the second end moveable relative to the base (paragraph 24 discloses the members being “transitioned into a deployed configuration”), the second securing member defining a second opening configured to receive a second portion of the vascular access device (see below),
PNG
media_image2.png
380
608
media_image2.png
Greyscale
wherein the first and second securing members are defined by a plurality of slits in the base (perforated section 52 in fig. 1A form the retaining members 50 and are shown to be in receiving portion 10; paragraph 26).
Regarding claim 2, Sniffin discloses the first opening has a first diameter and the second opening has a second diameter larger than the first diameter (see annotated figure above).
Regarding claim 3, Sniffin discloses wherein the first portion of the vascular access device comprises tubing (the examiner note that the first portion of the vascular device is functional due to the “configured to receive language in claim 1; as such, the device of Sniffin is fully capable of receiving the claimed first portion), and wherein the second portion of the vascular access device comprises a connector positioned on the tubing (the examiner note that the second portion of the vascular device is functional due to the “configured to receive language in claim 1; as such, the device of Sniffin is fully capable of receiving the claimed second portion).
Regarding claim 4, Sniffin discloses the first and second securing members each have a first position where the base and the first and second securing members are positioned coplanar (fig. 1A) and a second position where the first and second securing members are positioned at a non-zero angle relative to the base (fig. 1B).
Regarding claim 5, Sniffin discloses the non-zero angle is 45-135 degrees (fig. 1B).
Regarding claim 9, Sniffin discloses the first and second securing members are moveable relative to the base via a living hinge (paragraph 26).
Regarding claim 11, Sniffin discloses third securing member (retaining member 50 in fig. 1B, see below) including a first end connected to the base (end connected to receiving surface 10 in fig. 1B) and a second end positioned opposite from the first end (free end of retaining member 50 in fig. 1B), the second end moveable relative to the base (paragraph 24), the third securing member defining a third opening configured to receive a third portion of the vascular access device (see below).
PNG
media_image3.png
381
463
media_image3.png
Greyscale
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) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sniffin.
Regarding claim 6, Sniffin discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses the first opening comprises a spherical portion (see below) and an elongated portion (see below), the elongated portion extending from the second end of the first securing member to the spherical portion (fig. 1A).
PNG
media_image4.png
205
302
media_image4.png
Greyscale
However, Sniffin does not explicitly teach or disclose the elongated portion extends from the second end of the securing member to the spherical portion.
In another embodiment of the securing member (see below), Sniffin teaches the opening of the securing member comprises a spherical portion and an elongated portion which extends from the second end of the securing member to the spherical opening (see below). Sniffin further teaches that the securing members can comprise different perforation configuration or the same perforated configuration (paragraph 27). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the securing members of Sniffin to all comprise the perforated configuration of the securing member shown below as such modification appears aligned with the disclosure of Sniffin and would simplify manufacturing.
PNG
media_image5.png
204
336
media_image5.png
Greyscale
Regarding claim 7, in the modified device of Sniffin, Sniffin discloses the second opening comprises a spherical portion and an elongated portion (see below), the elongated portion extending from the second end of the second securing member to the spherical portion (see below).
PNG
media_image5.png
204
336
media_image5.png
Greyscale
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sniffin, as applied to claim 1 above, and further in view of Taylor (US 9746052).
Regarding claim 10, Sniffin discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses “substantially all” of the base can comprise an adhesive surface (paragraph 31). However, Sniffin does not explicitly teach or disclose the bottom surface of the base comprises an adhesive surface.
Taylor teaches a base (base portion 12 in fig. 1) which comprises a bottom surface with an adhesive surface (adhesive surface 16 in fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the bottom surface of Sniffin to comprise an adhesive surface, as taught by Taylor, in order to retain the base to a supporting surface (5:33-35).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sniffin, as applied to claim 1 above, and further in view of Feldstein (US 4795429).
Regarding claim 12, Sniffin discloses the secondary securement device of claim 1 (see discussion above) and further discloses that the device can retain a wide variety of tools (paragraph 23). However, Sniffin does not explicitly teach or disclose positioning tubing of the vascular access device within the first opening of the first securing member to secure the tubing; and positioning a connector of the vascular access device within the second opening of the second securing member to secure the connector.
Feldstein is directed towards a secondary securement device (matrix device 10 in fig. 1) which comprises the method steps of positioning tubing of the vascular access device (tubes 91 in fig. 1) within the first opening of the first securing member to secure the tubing (see below); and positioning a connector of the vascular access device (tubing 92 in fig. 1 is shown to connect to further components and is part of the overall vascular access device so as to be a “connector”) within the second opening of the second securing member to secure the connector (see below).
PNG
media_image6.png
252
350
media_image6.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Sniffin to include the steps of positioning tubing of the vascular access device within the first opening of the first securing member to secure the tubing; and positioning a connector of the vascular access device within the second opening of the second securing member to secure the connector, as taught by Feldstein, in order to adapt the device of Sniffin for intravenous fluid delivery, which appears within the scope of Sniffin.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sniffin in view of Feldstein as applied to claim 12 above, and further in view of Underwood (US 4654026).
Regarding claim 13, modified Sniffin teaches all of the claimed limitations set forth in claim 12, as discussed above. Sniffin further discloses the first opening comprises a spherical portion and an elongated portion (see below), the elongated portion extending to the spherical portion (see below), and wherein the second opening comprises a spherical portion and an elongated portion (see below), the elongated portion extending from the second end of the second securing member to the spherical portion (see below).
PNG
media_image7.png
342
578
media_image7.png
Greyscale
However, Sniffin does not explicitly teach or disclose that the elongated opening extending from the second end of the first securing member to the spherical portion. Additionally, modified Sniffin does not teach or disclose the steps of pushing the tubing of the vascular access device past the elongated portion of the first opening; and pushing the connector of the vascular access device past the elongated portion of the second opening.
However, Sniffin further teaches that the securing members can comprise different perforation configuration or the same perforated configuration (paragraph 27). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the securing members of Sniffin to all comprise the perforated configuration of the second securing member (see above) as such modification appears aligned with the disclosure of Sniffin and would simplify manufacturing.
Underwood is directed towards a similar securement device (fig. 2) which comprises two openings both comprising spherical portions (holes 30 in fig. 2) and elongated portions (slots 32 in fig. 2) and both receive a tubing and a connector, respectively (fig. 1 shows a tubing 12 and a tubing 11, which is shown to connect to further components so as to be a “connector”). Underwood further teaches the method step of pushing the tubing of the vascular access device past the elongated portion of the first opening and pushing the connector of the vascular access device past the elongated portion of the second opening (4:57-61 discloses opening the elongated portions 32 to snap the tubes into the holes 30).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of modified Sniffin to include the steps of pushing the tubing of the vascular access device past the elongated portion of the first opening and pushing the connector of the vascular access device past the elongated portion of the second opening, as taught by Underwood, in order to secure the components to the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. 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.
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights