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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/21/2026 has been entered.
Response to Amendment
The amendment filed 07/21/2026 has been entered. Claims 1-2, 4-15, 22-26 are pending in the application. Applicant’s amendments to the claims have every objection and 112(b) rejection previously set forth in the Final Office Action mailed 04/21/2026.
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.
Claims 1-2, 5-7, 9-13, 15, 22-23, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albany (US 2019/0388652).
Regarding Claim 1, Albany discloses an intravenous catheter securement device (10, Fig 1A) comprising: a holder (20, 60, Fig 1B) comprising: a continuous bottom surface (surface of membrane 62 forms a continuous ring-like shape as best seen in Figs 4B and 4D) with an anatomically-shaped support surface configured to conform to the shape of the bodily appendage (See Fig 1C wherein the holder is shaped to conform to a forearm) of a bodily appendage near an intravenous insertion site (Para 0121; See Fig 1C), a tray (60, Fig 1B) having an interior cavity (cavity formed by wall 61, Fig 4A) and a tearable lid (20, Fig 1B) sealing (Para 0009, “hermetic seal”) the interior cavity (Para 0141; As the tray and lid are only held together by a snap fit, the lid is able to be pulled apart from the tray. Examiner notes that Merriam-Webster defines tear as “to separate parts of or pull apart by force”. Thus, the lid is tearable from the tray); a strap (one of straps 80) for securing the holder to the bodily appendage (Para 0125); and at least one securement feature (25, 26, Fig 2F) formed on the holder and configured to secure at least a portion of an intravenous catheter (Para 0147), wherein the holder is shaped to surround at least a portion of the bodily appendage (See Fig 1C).
Regarding Claim 2, Albany discloses the at least one securement feature (25, 26, Fig 2F) is a slot formed on the holder (See Fig 2F and 2G).
Regarding Claim 5, Albany discloses the tray (60, Fig 1B) comprises at least one catheter accessory holder slot (65, Fig 4A) (Para 0129).
Regarding Claim 6, Albany discloses at least one tearable or easily removable strap (another one of straps 80) removably secured to the holder (Para 0125).
Regarding Claim 7, Albany discloses the at least one tearable or easily removable strap has at least one opening configured to receive at least a portion of bodily appendage (Para 0124-125).
Regarding Claim 9, Albany discloses at least one monitoring device connected to the holder and configured to detect at least one functional parameter (Para 0205-0206).
Regarding Claim 10, Albany discloses at least one monitoring device comprises at least one sensor configured to detect the at least one functional parameter that is a physiological parameter of the patient (Para 0206).
Regarding Claim 11, Albany discloses the at least one sensor is at least one of a moisture sensor; a temperature sensor; a blood pressure sensor; an accelerometer; and any combination thereof (Para 0206).
Regarding Claim 12, Albany discloses a communication device (wireless transmitter) in operative communication with the at least one monitoring device, the communication device configured for sending data from the at least one monitoring device to a patient or a remote site (Para 0207).
Regarding Claim 13, Albany discloses at least one remedy device (40, 41, 42) connected to the holder and configured to administer a remedy (Para 0008).
Regarding Claim 15, Albany discloses the intravenous catheter having a first end (42, Fig 1B) configured for connection to the intravenous insertion site (Para 0123) and a second end (40, Fig 1B) configured for connection to at least one of the at least one securement feature formed on the holder (Para 0147).
Regarding Claim 22, Albany discloses the tearable lid (20, Fig 1B) maintains sterility of the interior cavity prior to the tearable lid being removed (Para 0009; the cavity can be sterilized with a sterilizing gas, hermetically sealed, or UV LEDs).
Regarding Claim 23, Albany discloses the tray (60, Fig 1B) includes one or more chambers (chamber within catheter hub 40) pre-filled with a fluid (Para 0152, catheter hub can be pre-filled with fluid during priming).
Regarding Claim 25, Albany discloses the at least one tearable or easily removable strap has a plurality of finger holes (See loops or holes formed for receiving “fingers” 22 of the cover 20 in Fig 1B; the language of the claim does not require the fingers to be fingers of the patient).
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, 22, 23, 24, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Busch (US 6,769,546) in view of Gorek (US 2018/0185025).
Regarding claim 1, Busch discloses a catheter securement device comprising: a holder (10, Fig 1) comprising: a continuous bottom surface (22, Fig 3), a tray (12, Fig 1) having an interior cavity and a tearable lid (24, Fig 1) sealing the interior cavity; and at least one securement feature (32, Fig 3) formed on the holder and configured to secure at least a portion of a catheter (46, Fig 3).
Busch is silent regarding the securement device being an intravenous catheter securement device; a continuous bottom surface with an anatomically-shaped support surface configured to conform to the shape of a bodily appendage near an intravenous site; and a strap for securing the holder to the bodily appendage.
Gorek teaches an analogous kit for an intravenous catheter (Para 1522) and a holder (145, Fig 49) comprising a continuous bottom surface (bottom surface of 145, Fig 49) with an anatomically-shaped support surface configured to conform to the shape of a bodily appendage near an intravenous site (the bottom surface conforms to the forearm as seen in Fig 50; Para 1092); and a strap (175, Fig 49) for securing the holder to the bodily appendage (Para 1091).
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 to be an intravascular catheter securement device as it is known in the are the kits can be modified to accommodate specific procedures (Para 1522). Busch also states that the kit can find applications with other procedures (Col 7, lines 27-30). Further, 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 holder to comprise a bottom surface with an anatomically-shaped support surface configured to conform to the shape of a bodily appendage and a strap as taught by Gorek in order to have a holder that is quickly attachable to a user’s arm to allow for efficient and ergonomic access to devices (Para 0013, 0017).
Regarding Claim 22, The modified invention of Busch and Gorek discloses the tearable lid maintains sterility of the interior cavity prior to the tearable lid being removed (Col 2, line 64 – Col 3, line 10 -Busch).
Regarding claim 23, The modified invention of Busch, Gorek, and Smith discloses the tray includes one or more chambers (34, Fig 3 -Busch) pre-filled with a fluid (Col 5, lines 48-62 -Busch).
Regarding claim 24, The modified invention of Busch and Gorek discloses each of the one or more chambers (34, Fig 3 -Busch) is sealed with a removable lid (64, Fig 4 -Busch) (Col 5, lines 48-62 -Busch).
Regarding Claim 26, The modified invention of Busch and Gorek discloses a medical device (50, Fig 3 -Busch) stored in the interior cavity, wherein the tearable lid maintains sterility of the medical device prior to use of the medical device (Col 2, line 64 – Col 3, line 10 -Busch).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Albany (US 2019/0388652) in view of Pickering (US 2021/0370025).
Regarding Claim 4, Albany discloses all of the elements of the invention as discussed above, however, is silent regarding the tray has a foam insert in at least a portion of the interior cavity.
Pickering teaches an intravenous catheter securement device (10, Fig 5) comprising a holder having a tray (12, Fig 5) and a lid (22, Fig 5), wherein the tray has a foam insert (12b, Fig 5) in at least a portion of the interior cavity (Para 0051).
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 tray to include a foam insert as taught by Pickering in order to have a tray with increased frictional forces to counter sliding thereon (Para 0051).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Albany (US 2019/0388652) in view of Caywood (US 2021/0100983).
Regarding Claim 8, Albany discloses all of the elements of the invention as discussed above, however, is silent regarding the holder is made of foam.
Caywood teaches an analogous holder (300, Fig 3b) for securing and protecting a catheter wherein the holder can be made of foam (Para 0024).
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 holder to be made of foam in order to allow clothing to glide across without catching and to be able to deform and compress when pressed against and then spring back to its original shape to continue protecting the infusion site (Para 0024).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Albany (US 2019/0388652) in view of Joseph (US 2016/0375104).
Regarding Claim 14, Albany discloses all of the elements of the invention as discussed above, however, is silent regarding the at least one remedy device is a massager configured to stimulate an area around the insertion site.
Joseph teaches a remedy device (3, Fig 7B) connected to a holder (1, Fig 7B) wherein the remedy device is a massager configured to stimulate an area around the insertion site (Para 0115, 0118).
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 holder to include a massager as taught by Joseph in order to increase absorption of the pharmaceutical formulation by increasing blood circulation to the area (Para 0013, 0152)
Response to Arguments
Applicant’s argument filed 07/21/2026, On pages 6-8, regarding Albany failing to teach a continuous bottom surface have been fully considered, but are not persuasive. As detailed in the rejection above, Albany’s bottom surface of membrane 62 forms a continuous ring-like shape as best seen in Figs 4B and 4D. It is continuous in an annular direction. The claim is not narrow enough to require no openings in the bottom surface.
Applicant’s argument filed 07/21/2026, On pages 8, regarding Busch, Gorek, and Smith failing to teach the continuous bottom with an anatomically-shaped support surface configured to conform to the shape of a bodily appendage have been fully considered but are not persuasive. The current rejection relies on a new ground of rejection in view of Gorek as Gorek teaches a holder (145, Fig 49) comprising a continuous bottom surface (bottom surface of 145, Fig 49) with an anatomically-shaped support surface configured to conform to the shape of a bodily appendage near an intravenous site (the bottom surface conforms to the forearm as seen in Fig 50; Para 1092). Thus, Busch and Gorek teach all of the amended limitations. Applicant also argues that Smith does not teach the claimed strap. This argument is moot in view of the current rejection that no longer relies on Smith to teach the strap.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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