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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/27/2026 has been entered.
Response to Amendment
The Amendment filed on 8/27/2026 has been entered. Claims 1-14 and 16-20 remain pending in the application. Claim 21 is new. Claims 11-13 and 19 have been withdrawn from consideration as detailed in the Non-final Office Action mailed 4/17/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 6/2/2026.
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 1-10 and 14 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.
In regard to claim 1,
Line 12-13 recites “the second end of the tail portion”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “the second end of the tail portion” refers to a second end of the tail portion or the second input end of the Y-site infusion set component. For examination purposes Examiner construes “the second end of the tail portion” to be “a second end of the tail portion”. Examiner suggests replacing “the second end of the tail portion” in line 12-13 of claim 1 with “a second end of the tail portion”.
Examiner notes claims 2-10 and 14 are similarly rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 103
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 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 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Korogi (U.S. PG publication 20100292673) further in view of Wong (U.S. PG publication 20070106229).
In regard to claim 16,
[AltContent: ][AltContent: textbox (Tail portion)][AltContent: textbox (Sliding surface)][AltContent: ][AltContent: connector][AltContent: textbox (Covering portion)][AltContent: connector][AltContent: ][AltContent: textbox (Outlet port)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Fluid connector component)][AltContent: textbox (Needless connector)][AltContent: arrow][AltContent: textbox (Anti-snagging component)][AltContent: connector][AltContent: ]
PNG
media_image1.png
546
298
media_image1.png
Greyscale
PNG
media_image1.png
546
298
media_image1.png
Greyscale
Korogi discloses an intravenous (IV) infusion set (see figure 39), comprising:
a fluid connector component (see figure 39 above) comprising:
a first inlet port comprising a needless connector (see figure 39 above), and
an outlet port (see figure 39 above);
an anti-snagging component (see figure 39 above) comprising:
a covering portion (see figure 39 above) configured to cover an access point of the needleless connector (see figure 39 above) in an engaged position (see position shown in figure 39) and to uncover the access point of the needleless connector in a disengaged position (paragraph [0143], position when the cover is removed from the fluid connector; Examiner notes “configured to cover an access point of the needleless connector in an engaged position and to uncover the access point of the needleless connector in a disengaged position” is a functional limitation. The covering portion is fully capable of the intended function due to its structure); and
a tail portion (see figure 39 above) slidingly and rotationally coupled to the needleless connector (see figure 39 wherein as a result of the tail portion being slidingly and rotationally coupled to the fluid connector component, the tail portion is also slidingly and rotationally coupled to the needleless connector via the fluid connector component), the tail portion comprising an end of the anti-snagging component (see figure 39 above); and
a sliding surface (figure 39 above) disposed between and directly coupled to the covering portion and the tail portion (see figure 39; wherein the sliding surface is disposed between the covering portion and the tail portion), the sliding surface configured to slidingly guide the fluid connector component past an obstruction without snagging when the IV infusion set is moved (Examiner notes “configured to slidingly guide the IV infusion set past an obstruction without snagging when the IV infusion set is moved” is a functional limitation. The sliding surface is fully capable of slidingly guiding the fluid connector component past an obstruction without snagging when the IV infusion set is moved due to its structure, since the sliding surface is a smooth surface. Examiner notes the size or shape of the obstruction is not further claimed).
Although Korogi supports the anti-snagging component can be used with a y-site infusion set component (paragraph [0008]), the first embodiment of figure 39 of Korogi is silent as to a Y-site infusion set component comprising: a first inlet port comprising a needleless connector; a second inlet port; and an outlet port; an inlet IV tube coupled to the second inlet port; an outlet IV tube coupled to the outlet port. As a result, Korogi fails to disclose a tail portion slidingly and rotationally coupled to the inlet IV tube and the sliding surface configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the IV infusion set is moved.
Wong teaches a Y-site infusion set component (figure 2, item 1, 2 and 3) comprising: a first inlet port (port which item 4 connects to) comprising a needleless connector (figure 2, item 3; paragraph [0030]); a second inlet port (port of item 12 which item 6 is received in; paragraph [0030]); and an outlet port (port which item 7 is directly connected to and which receives fluid as detailed in paragraph [0030]); an inlet IV tube (figure 4, item 6) coupled to the second inlet port (see figure 4); an outlet IV tube (figure 4, item 7) coupled to the outlet port (see figure 4; paragraph [0030].
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid connector component of Korogi to include branch port 12 and tubing 6 and 7 of Wong, as taught by Wong, therefore resulting in a Y-site infusion set component comprising: a first inlet port comprising a needleless connector; a second inlet port; and an outlet port; an inlet IV tube coupled to the second inlet port; an outlet IV tube coupled to the outlet port, for the purpose of enabling multiple fluids to be delivered (paragraph [0030] of Wong). As a result of the fluid connector component being modified to be a Y-site infusion set component which has an inlet IV tube coupled to the second inlet port, the tail portion of Korogi would be slidingly and rotationally coupled to the inlet IV tube since the tail portion is slidingly and rotationally coupled to the Y-site infusion set component, and the inlet IV tube is coupled to the Y-site infusion set component. The claim does not require the tail portion to be directly coupled to the inlet IV tube. Additionally, the sliding surface is configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the IV infusion set is moved as a result of the fluid connector component being modified to be a Y-site infusion set component.
In regard to claim 17,
Korogi in view of Wong teaches the IV infusion set of Claim 16.
The first embodiment of Korogi in view of Wong is silent as to wherein the tail portion comprises a tube connection point that encircles the inlet IV tube, the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube.
A second embodiment of Korogi teaches wherein the tail portion (portion which connects the cover to a housing; paragraph [0103]) comprises a tube connection point that encircles the inlet IV tube (paragraph [0103] wherein the cover may be connected to a connector housing via a strap around the extension set tubing/inlet IV tube), the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube (Paragraph [0103] supports the tail portion is capable of encircling an inlet IV tube. “Configured to slide along the inlet IV tube and to rotate around the inlet IV tube” is a functional limitation. The tube connection point is fully capable of the intended function due to its structure. Since the tube connection point is capable of being slid onto and rotated on an appropriately sized inlet IV tube to connect the tube connection point with the inlet IV tube, the tube connection point is configured to slide along the inlet IV tube and to rotate around the inlet IV tube).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Korogi in view of Wong to substitute item 307-3 of the tail portion of the first embodiment which is a connection point, for a tube connection point that encircles the inlet IV tube, the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube of the second embodiment, as taught by the second embodiment of Korogi, because the substitution is a simple substitution that would yield the same predictable result of connecting a cover (paragraph [0103]). Furthermore, Korogi discloses modifications can be made (paragraph [0165]).
In regard to claim 18,
[AltContent: textbox (Side wall)][AltContent: arrow][AltContent: textbox (Top surface)][AltContent: arrow]
PNG
media_image1.png
546
298
media_image1.png
Greyscale
Korogi in view of Wong teaches the IV infusion set of Claim 16, wherein the covering portion is a cap (see figure 39 above) comprising: a top surface (see figure 39 above) configured to cover the access point in the engaged position (see figure 39 above); and a side wall (see figure 39 above) configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 39 above).
The first embodiment of Korogi in view of Wong fails to disclose wherein the side wall comprises one of: one or more slits configured to allow expansion of the side wall when the cap slides onto the needleless connector; a flexible material configured to stretch when the cap slides onto the needleless connector; and internal threads configured to mate with threads of the needleless connector when the cap is screwed onto the needleless connector.
A third embodiment of Korogi teaches wherein the covering portion (figure 6, item 112) is a cap (see figure 6) comprising: a top surface configured to cover the access point in the engaged position (see figure 6); and a side wall configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 6), wherein the side wall comprises one or more slits (figure 6, item 115) configured to allow expansion of the side wall when the cap slides onto the needleless connector (paragraph [0128]; Examiner notes “configured to allow expansion of the side wall when the cap slides onto the needleless connector” is a functional limitation).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the side wall of the first embodiment of Korogi in view of Wong to include wherein the side wall comprises one of: one or more slits configured to allow expansion of the side wall when the cap slides onto the needleless connector, as taught by the third embodiment of Korogi, for the purpose of enabling the cover to be used with variable sized valves (paragraph [0086] of Korogi).
In regard to claim 20,
Korogi in view of Wong teaches the IV infusion set of Claim 16.
The first embodiment of Korogi in view of Wong fails to disclose wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion and configured to contact the access point in the engaged position.
A fourth embodiment of Korogi teaches wherein the covering portion (removable lidding described in paragraph [0151]) comprises an anti-microbial coating disposed on an inner surface of the covering portion (paragraph [0151]) and configured to contact the access point in the engaged position (paragraph [0151]; “Configured to contact the access point in the engaged position” is a functional limitation. Due to the anti-microbial coating being disposed on an inner surface, it is fully capable of contacting the access point in the engaged position since the covering portion contacts the access point in the engaged position).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner surface of the first embodiment of Korogi in view of Wong to include wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion and configured to contact the access point in the engaged position as taught by the fourth embodiment of Korogi, for the purpose of providing an antimicrobial agent to reduce unwanted bacteria (paragraph [0151] of Korogi).
Allowable Subject Matter
Claims 1-10 and 14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 1,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations an anti-snagging assembly as claimed in claim 1 comprising the second end of the tail portion is connected to a tube connection point encircling the input tube in combination with a first end of the tail portion is connected to the sliding surface and the sliding surface directly coupling the covering portion to the tail portion.
Korogi (U.S. PG publication 20100292673) discloses an anti-snagging assembly (see all of figure 40 below; paragraph [0144]) comprising an anti-snagging component (see figure 40 below; paragraph [0144]) comprising a covering portion (see figure 40 below), a tail portion (see figure 40 below), and a sliding surface (see figure 40 below), wherein a first end of the tail portion is connected to the sliding surface (see figure 40 below).
PNG
media_image2.png
481
490
media_image2.png
Greyscale
PNG
media_image3.png
478
351
media_image3.png
Greyscale
Korogi fails to disclose the second end of the tail portion is connected to a tube connection point encircling the input tube. The subject matter of the second end of the tail portion is connected to a tube connection point encircling the input tube in combination with a first end of the tail portion is connected to the sliding surface and the sliding surface directly coupling the covering portion to the tail portion, and in combination with all other limitations of claim 1 could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Dependent claims 2-10 and 14 would be allowable by virtue of being dependent upon allowable independent claim 1.
Claim 21 is allowed.
The following is an examiner’s statement of reasons for allowance:
In regard to claim 21,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations an anti-snagging assembly as claimed in claim 21 comprising a portion of the sliding surface being disposed on a top surface of covering portion.
Korogi (U.S. PG publication 20100292673) discloses an anti-snagging assembly (see figure 39) comprising an anti-snagging component (see figure 39 below) comprising: a covering portion (see figure 39 below), a tail portion (see figure 39 below), and a sliding surface (see figure 39 below).
PNG
media_image4.png
543
669
media_image4.png
Greyscale
Korogi fails to disclose a portion of the sliding surface being disposed on a top surface of covering portion. The subject matter of a portion of the sliding surface being disposed on a top surface of covering portion in combination with all other limitations of claim 21 could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 21 is allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 8/27/2026 in regard to claim 16-18 and 20 have been fully considered but they are not persuasive. Applicant argues in regard to claim 16 that the alleged tail portion of Korogi is connected to a remainder portion of the Korogi anti-snagging component. It is noted that claim 16 does not require the same limitations as amended claim 1. Claim 16 also does not require the anti-snagging component or the end of the anti-snagging component to be directly connected/surrounding the infusion set component or the inlet IV tube. As shown in figure 39 of Korogi above, the tail portion does comprise an end of the anti-snagging component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 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, 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.
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.
/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights