DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 8/28/2025. These drawings are accepted.
The accompanying specification amendments are also acknowledged.
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) 1-5, 7-8, 11-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2011/0130728) in view of Insignia.
In regard to claims 1 and 11, McKinnon discloses an intravenous set (10; see Figs. 13-15 and Fig. 20), comprising: a plurality of connected intravenous set components (see multiple components shown in Figures 13 and 20 including shell and septum); and an intravenous set timer device (label 138 or 162), comprising: an indicator portion (148) configured to change color at one or more predetermined times upon activation (see par. [0083]); a legend portion (140), wherein the legend portion defines relationships between colors of the indicator portion and specific time periods; and wherein the intravenous set time device is integrally formed as a portion of the material forming an intravenous set component (see especially par. [0080] and [0141]; McKinnon describes integrated and integral status indicators in addition to the label embodiments; see par. [0079], [0122]-[1023], [1026], [0129], and [0141] for further support)
McKinnon fails to expressly disclose a removable protective cover configured to prevent exposure of the indicator portion to air when the removable protective cover is disposed on the indicator portion, wherein the indicator portion is configured to be activated when the removable protective cover is removed from the indicator portion. The examiner notes that McKinnon does discuss removable covers for some embodiments but it is not clear that this embodiment includes such a cover. McKinnon discloses embodiments sensitive to light and embodiments sensitive to oxygen (see par. [0084]).
In a similar art, Insignia includes a removable protective cover (see annotated figure above) configured to prevent exposure of the indicator portion to air when the cover is disposed on the indicator portion, wherein the indicator portion is configured to be activated when the removable protective cover is removed from the indicator portion (clearly shown in the video).
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 McKinnon with the removable cover of Insignia in order to provide a means for selective activation of the timing device. The ordinary skilled artisan would appreciate the need to have a timing activation means because otherwise the device would be delivered to the user in an exhausted state. The references are analogous in that they are trying to solve the same issue as the applicant, namely providing a timer device for condition sensitive devices.
In regard to claims 2 and 12, Insignia teaches wherein the indicator portion is a circle and wherein the legend portion is disposed around a portion of an outer perimeter of the circle (see annotated figure above and video).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the timing configuration of Insignia on the device of McKinnon because it provides a suitable means for tracking the use time of the device.
In regard to claims 3 and 13, Insignia teaches wherein the legend portion comprises a plurality of sections, each section being a color that matches a color of the indicator portion at one of the predetermined times (see annotated figure above and video).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the timing configuration of Insignia on the device of McKinnon because it provides a suitable means for tracking the use time of the device.
In regard to claims 4 and 14, McKinnon discloses, further comprising: a printed word legend describing the time period associated with each legend color (see “12 Hours”, “24 Hours”, etc).
In regard to claim 5, Insignia teaches, further comprising: an instruction portion (see annotated figure above) disposed around a portion of the outer perimeter of the circle, the instruction portion being a color that matches a color of the indicator portion at a predetermined expiration time (the indicator portion and instruction portion are both yellow at the expiration time; see video).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the timing configuration of Insignia on the device of McKinnon because it provides a suitable means for tracking the use time of the device.
In regard to claims 7-8 and 16, Insignia teaches wherein the removable protective cover comprises one of: a peel off label disposed on an outer surface of the indicator portion (see annotated figure above); an airtight package containing the intravenous set timer device; and a vacuum sealed package containing the intravenous set timer device (the removable air-tight lid can be considered as part of the removable protective cover).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the timing configuration of Insignia on the device of McKinnon because it provides a suitable means for tracking the use time of the device.
In regard to claim 17, McKinnon discloses wherein the intravenous set includes intravenous tubing and the intravenous set timer device is attached to the intravenous tubing (see Figs. 13-15 and Fig. 20; attached via other structures).
In regard to claim 18, McKinnon discloses wherein the intravenous set includes a drip chamber (320) and the intravenous set timer device is disposed on the drip chamber (see Fig. 44).
Claim(s) 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon in view of Insignia and further in view of Hu.
In regard to claims 6 and 15, the combination is silent regarding a printed word instruction describing an action to be taken when the indicator portion changes to match the instruction portion color.
In a similar art, Hu discloses a temperature-time integrating indicator (10) comprising pouches with message-conveying means (15) with printed word instructions describing an action when the timer has been activated (see messages “USE FIRST” and “DISCARD” in Fig. 3). The message explicitly informs the user that the device should be discarded at the end of use.
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 the combination with the printed word instructions of Hu in order to provide a messaging means to inform the user that the device is no longer useable and should be thrown away.
Response to Arguments
Applicant’s arguments, see Remarks, filed 8/28/2025, with respect to the 102 rejection over Insignia have been fully considered and are persuasive. The 102 rejection over Insignia has been withdrawn.
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive. The applicant argues that McKinnon fails to disclose or suggest that the timer device is integrally formed as a portion of the material forming the intravenous set component. This argument is not persuasive. The examiner agrees that McKinnon does disclose adhesive label embodiments (similar to Insignia) which fail to disclose the amended limitations but McKinnon further discloses integrated and integrally formed embodiments as well. In par. [0080], McKinnon teaches that the label 162 may be integrated into the device 10. This is understood to mean that the label is formed as part of the device and therefore the material of the label can also be considered a part of the intravenous set component. Par. [0141] gives further support as well as the paragraphs cited in the body of the rejection.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783