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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 5/15/2026 is acknowledged. Non-elected claims 6-9, 11, 13, 28, 30, 33, 34 are withdrawn.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22, 24, 27, 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boque et al (US 2017/0143553).
Regarding claim 22, Boque discloses an Intravenous (IV) infiltration detection system (page 1, para. 0016), comprising: a patch having a first side and a second side (fig. 5), with an adhesive 102 disposed on a perimeter of the second side (fig. 5; page 1, para. 0017), the adhesive configured to secure the patch to skin of a patient around an IV insertion site (page 2, para. 0018; figs. 1, 4); and an absorbent material 104 coupled to the first side of the patch, the absorbent material impregnated with a dye 106 (page 2, para. 0022: hydrochromatic layer is a liquid ink which impregnates the mesh).
Regarding claim 24, Boque discloses that the patch comprises a transparent center portion configured to enable view of an IV insertion site (fig. 4; page 2, para. 0020).
Regarding claim 27, Boque discloses that the absorbent material 104 is disposed around a perimeter of the first side of the patch (fig. 5).
Regarding claim 31, Boque discloses a method, comprising: adhering, by a patch comprising at least one visible indicator 134 (fig. 4), to skin of a patient having an intravenous (IV) insertion site (fig. 1); and outputting, by the at least one visible indicator, at least one visible indication of IV infiltration of the patient (page 1, para. 0016; page 2, para. 0022).
Claim(s) 31, 32, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yong (US 11,883,629).
Regarding claim 31, Yong discloses a method, comprising: adhering, by a patch comprising at least one visible indicator 131, 312 (figs. 2, 3; col. 5, lines 61-62) , to skin of a patient having an intravenous (IV) insertion site (col. 5, lines 32-35); and outputting, by the at least one visible indicator, at least one visible indication of IV infiltration of the patient (fig. 2, 3; col. 5, lines 41-48).
Regarding claim 32, Yong discloses that the at least one visible indication of IV infiltration of the patient comprises: revealing the at least one visible indication in response to swelling of the skin of the patient (fig. 3; col. 5, lines 41-48).
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) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boque in view of Simmons et al (US 2014/0358121).
Claim 23 differs from Boque in calling for the dye to comprises methylene blue. Simmons teaches an adhesive dressing for covering an IV site, wherein the dressing includes a liquid indicator dye wherein the dye may be methylene blue which is known to be biological benign and hypoallergenic and provides a reliable color indication (page2, para. 0025). 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 dye of Boque to be methylene blue as taught by Simmons because methylene blue is inert and hypoallergenic and is therefore same for use on or near the skin and provides a reliable indication color change.
Claim(s) 25, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boque in view of Van Antwerp et al (US 6,461,329).
Regarding claim 25, Boque discloses that the absorbent material is impregnated with the dye at the edge of the patch (page 2, para. 0022). Claim 25 differs from Boque in calling for the absorbent material to comprise a moisture-wicking material that extends from a center portion of the patch to an edge of the patch. Van Antwerp teaches a patch for an infusion site wherein the patch includes material such as fibrous material that wick fluid away from the insertion site towards the edges of the pad so that the color change from the reaction can be seen around the edges of the delivery device (col. 6, line 65 – col. 7, line 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 absorbent material of Boque to comprise a moisture-wicking material that extends from a center portion of the patch to an edge of the patch as taught by Van Antwerp to ensure that any fluid leaking from the insertion site quickly reaches the color changing material so that the user is alerted to the leak.
Claim 35 differs from Boque in calling for the steps of causing the patch to change color by wicking, by an absorbent material in the patch, liquid leaking from the IV insertion site to a dye in the patch. Boque teaches the step of the patch changing color by liquid leaking into the absorbent material (page 2, para. 0033), but fails to disclose the step of wicking. Van Antwerp teaches a patch for an infusion site wherein the patch includes material such as fibrous material that wick fluid away from the insertion site towards the edges of the pad so that the color change from the reaction can be seen around the edges of the delivery device (col. 6, line 65 – col. 7, line 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 absorbent material of Boque to comprise the step of wicking the liquid via a moisture-wicking material as taught by Van Antwerp to ensure that any fluid leaking from the insertion site quickly reaches the color changing material so that the user is alerted to the leak.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yong in view of Rothenberg et al (US 2023/0001105).
Claim 36 calls for the step of generating, by an imaging device, image data of the patch; and determining a swelling state associated with the patient based on the image data. Yong discloses that the patch is monitored to determine swelling, but fails to disclose an imaging device. Rothenberg teaches a system for monitoring a catheter insertion site including an imaging device that captures an image of the patch and processes the image to determine the status of the catheter insertion site (page 3, para. 0037). 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 device of Yong to include an imaging device that captures an image of the patch and processes the image to determine the status of the catheter insertion site as taught by Rothenberg to automate the monitoring to reduce the burden on healthcare providers to monitor multiple patients simultaneously.
Allowable Subject Matter
Claim 29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach or fairly suggest an IV infiltration detection system comprising a first indicator strip formed of a flexible material, the first indicator strip comprising: a first adhesive disposed on a first end of the first indicator strip; and a visible indicator disposed on a second end of the first indicator strip; and a second indicator strip formed of a flexible material, the second indicator strip comprising: a second adhesive disposed on a first end of the second indicator strip, wherein a second end of the second indicator strip defines a socket configured to slidably couple with the visible indicator of the first indicator strip and reveal the visible indicator in response to swelling of the skin of the patient, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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