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 .
Status of Claims
The claims filed 02/17/2023 are still pending. No new amendments have been filed. Claims 1-20 are pending in the application.
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 1-10, 12-14, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Allen (US 2014/0364835) in view of Antonini (US 5,361,781).
Regarding Claim 1, Allen discloses a medical assembly comprising: a sheath (392, Fig 57E) having a channel that extends therethrough; a medical device (3104, Fig 57E) that extends into the channel of the sheath via a proximal end of the sheath (Para 0202).
Allen is silent regarding a cover at least partially enclosing a space and having a first opening that provides access to the space, wherein the sheath extends through the first opening such that the medical device emerges from the proximal end of the sheath within the space.
Antonini teaches a cover (10, Fig 1) at least partially enclosing a space and having a first opening (opening near flap 27, Fig 5) that provides access to the space, wherein a sheath (40, Fig 7) extends through the first opening such that the medical device (35, Fig 7) emerges from the proximal end of the sheath within the space (See Fig 9; Col 3, line 53 – Col 4, line 10).
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 medical assembly disclosed by Allen to include a cover as taught by Antonini in order to prevent the unwanted broadcasting of fluids which might contaminate a healthcare worker or patient (Abstract).
Regarding Claim 2, the modified invention of Allen and Antonini discloses the cover (10, Fig 1 -Antonini) defining a second opening (opening near tab 24, Fig 5 -Antonini) that provides access to the space, wherein the medical device extends through the second opening, into the space, and then into the channel of the sheath through the proximal end of the sheath (See Fig 5 -Antonini; Para 0202, Fig 57E -Allen).
Regarding Claim 3, the modified invention of Allen and Antonini discloses the cover (10, Fig 1 -Antonini) comprising a sheet (11, Fig 1 -Antonini) having a first sheet portion (13, Fig 1 -Antonini) and a second sheet portion (14, Fig 1 -Antonini), wherein the sheet is folded along a fold line (15, Fig 1 -Antonini) such that the first and second sheet portions substantially overlie one another to define the space therebetween (Col 2, lines 52-67 -Antonini).
Regarding Claim 4, the modified invention of Allen and Antonini discloses the cover (10, Fig 1 -Antonini) comprising an adhesive system (19-20, 25, Fig 1 -Antonini) that bonds the first and second sheet portions together about a perimeter of the space (Col 3, lines 46-52 -Antonini).
Regarding Claim 5, the modified invention of Allen and Antonini discloses the space is partially circumscribed by an inner crease of the sheet and the adhesive system (Col 3, lines 46-52 -Antonini).
Regarding Claim 6, the modified invention of Allen and Antonini discloses the adhesive system (19-20, 25, Fig 1 -Antonini) comprising a first adhesive segment (20, Fig 1 -Antonini) and a second adhesive segment (25, Fig 1 -Antonini) that define a gap therebetween, wherein the medical device extends through the gap into the space (See Fig 5 -Antonini).
Regarding Claim 7, the modified invention of Allen and Antonini discloses the first sheet portion (13, Fig 1 -Antonini) comprising a medial edge that is attached to the second sheet portion (14, Fig 1 -Antonini) along the fold line (fold line 15, Fig 1 -Antonini), and a lateral edge opposite to the medial edge, wherein the adhesive system (19-20, 25, Fig 1 -Antonini) comprises a first adhesive segment (19, Fig 1 -Antonini) that extends along and adjacent to the lateral edge.
Regarding Claim 8, the modified invention of Allen and Antonini discloses the first sheet portion (13, Fig 1 -Antonini) comprising a proximal edge that extends between a proximal end of the medial edge and a proximal end of the lateral edge, wherein the adhesive system further comprises one or more adhesive segments (25, Fig 1 -Antonini) that extend along and adjacent to the proximal edge (See Fig 1 -Antonini).
Regarding Claim 9, the modified invention of Allen and Antonini discloses the cover comprising a gauze layer (17, Fig 1 -Antonini) within the space and attached to the sheet (Col 2, lines 61-66 -Antonini).
Regarding Claim 10, the modified invention of Allen and Antonini discloses the sheet (11, Fig 1 -Antonini) is transparent or semitransparent (Col 2, lines 57-59 -Antonini).
Regarding Claim 12, the modified invention of Allen and Antonini discloses the medical device (3104, Fig 57E -Allen) is a catheter (Para 0202 -Allen).
Regarding Claim 13, Allen discloses a method of forming a medical assembly, comprising: withdrawing a medical device (398, Fig 57D) from the sheath (3104, Fig 57D) such that a distal end of the medical device emerges from the proximal end of the sheath (Para 0203)
Allen is silent regarding folding a sheet assembly such that opposing sheet portions thereof are caused to overlie one another thereby defining a cover having a space therein accommodating a proximal end of a sheath within the space, such that the sheath extends outside the space through a first opening in the cover and wherein material eluted from the distal end of the medical device upon emerging from the sheath will be captured and retained within the space of the cover.
Antonini teaches folding a sheet assembly (10, Fig 1) such that opposing sheet portions thereof are caused to overlie one another thereby defining a cover having a space therein accommodating a proximal end of a sheath (40, Fig 7) within the space (Col 3, lines 46-52), such that the sheath extends outside the space through a first opening (opening near flap 27, Fig 5) in the cover and wherein material eluted from the distal end of the medical device (35, Fig 7) upon emerging from the sheath will be captured and retained within the space of the cover (Col 3, line 53 – Col 4, line 10).
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 method to include folding a sheet to define a cover wherein material eluted from the distal end of the medical device upon emerging from the sheath will be captured and retained within the space of the cover as taught by Antonini in order to prevent the unwanted broadcasting of fluids which might contaminate a healthcare worker or patient (Abstract).
Regarding Claim 14, the modified invention of Allen and Antonini discloses bonding together the opposing first and second sheet portions about a perimeter of said space via a first adhesive system (19-20, 25, Fig 1 -Antonini) provided on the sheet (Col 3, lines 46-52 -Antonini).
Regarding Claim 18, the modified invention of Allen and Antonini discloses a method of confining material eluted from the medical device according to claim 1 (See rejection of claim 1 above), comprising: retracting the medical device from the channel of the sheath such that a distal end of the medical device emerges from the proximal end of the sheath within said space, wherein material eluted from the distal end of the medical device is at least partially confined within said space (Col 3, line 53 – Col 4, line 10 -Antonini).
Regarding Claim 19, the modified invention of Allen and Antonini discloses the cover (10, Fig 1 -Antonini) defining a second opening (opening near tab 24, Fig 5 -Antonini) that provides access to the space, wherein the medical device is retracted such that it translates through the space and second opening (Col 3, line 53 – Col 4, line 10 -Antonini).
Regarding Claim 20, the modified invention of Allen and Antonini discloses a gauze layer (17, Fig 1 -Antonini) within the space, wherein the medical device is retracted until its distal end is located adjacent to the gauze layer (Col 2, lines 61-66 -Antonini).
Claims 11, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Allen (US 2014/0364835) in view of Antonini (US 5,361,781) and further in view of Serivens (US 4,033,341).
Regarding Claim 11, the modified invention of Allen and Antonini discloses the cover comprises an adhesive system (29, Fig 2 -Allen) that affixes the cover adjacent to a target site (Col 3, lines 43-45), however, is silent regarding a drape having an aperture that the sheath extends therethrough, wherein the cover affixed to the drape such that the first opening of the cover is disposed adjacent to the aperture in the drape.
Serivens teaches an analogous medical assembly comprising a cover (40, Fig 1) and a drape (20, Fig 1) having an aperture (30, Fig 1) that the medical elements extends therethrough, wherein the cover comprises an adhesive system (65, Fig 3) that affixes the cover to the drape such that the first opening (45, Fig 5a) of the cover is disposed adjacent to the aperture in the drape (See Fig 1; Col 5, lines 9-16).
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 medical assembly to comprise a drape and affix the cover to the medical drape in order to a have clean field for carrying out the procedure (Col 1, lines 24-36 -Antonini) and have an improved means for covering and securing flexible members to the drape during the procedure (Col 1, lines 7-12 - Serivens).
Regarding Claim 15, the modified invention of Allen and Antonini discloses the cover comprises an adhesive system (29, Fig 2 -Allen) that affixes the cover adjacent to a target site (Col 3, lines 43-45), however, is silent regarding a drape having an aperture that the sheath extends therethrough, wherein the cover affixed to the drape such that the first opening of the cover is disposed adjacent to the aperture in the drape.
Serivens teaches an analogous medical assembly comprising a cover (40, Fig 1) and a drape (20, Fig 1) having an aperture (30, Fig 1) that the medical elements extends therethrough, wherein the cover comprises an adhesive system (65, Fig 3) that affixes the cover to the drape such that the first opening (45, Fig 5a) of the cover is disposed adjacent to the aperture in the drape (See Fig 1; Col 5, lines 9-16).
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 medical assembly to comprise a drape and affix the cover to the medical drape in order to a have clean field for carrying out the procedure (Col 1, lines 24-36 -Antonini) and have an improved means for covering and securing flexible members to the drape during the procedure (Col 1, lines 7-12 - Serivens).
Regarding Claim 16, the modified invention of Allen, Antonini, and Serivens prior to folding the sheet, the sheet assembly is arranged such that the sheet is interposed between the drape and the medical device (Col 3, lines 35-52 -Antonini; The first step for using the cover is adhering it via adhesive strip 29 between the patient and the medical device. This is followed by folding the sheet. Thus, the modified invention in view of Serivens would have the cover being adhered to the drape instead of to the patient).
Regarding Claim 17, prior to folding the sheet: arranging the sheet assembly such that said edge of the sheet is located adjacent to the aperture, and then bonding the sheet to the drape via an adhesive system provided on the sheet (Col 3, lines 35-52 -Antonini; The first step for using the cover is adhering it via adhesive strip 29 between the patient and the medical device. This is followed by folding the sheet. Thus, the modified invention in view of Serivens would have the cover being adhered to the drape instead of to the patient).
Response to Arguments
Applicant’s arguments filed 02/02/2026, on pages 2-4, regarding Allen and Antonini not being able to be combined as Allen does not provide any hint of any need for containment of secretions upon withdrawal have been fully considered but are not persuasive. Allen teaches a catheter that is not only coming into contact with bodily fluids, but can be used to deliver hazardous drugs such as radioembolic substances that a healthcare worker would not want to get on themselves or on the patient (Para 0030, 0121). So, while Allen is not concerned with secretions like Antonini, one of ordinary skill may still understand the inherent risk of contamination and look for ways of preventing this contamination. Thus, there is ample motivation for one of ordinary skill to look to Antonini for a way to prevent contamination of the healthcare provider and patient with potentially hazardous fluids during the removal of the catheter.
Applicant’s arguments filed 02/02/2026, on pages 4-5, regarding Antonini failing to teach wherein the sheath extends through the first opening such that the medical device emerges from the proximal end of the sheath within the space have been fully considered but is no persuasive. In the rejection above, the dressing 40 of Antonini is equated to a sheath and the tubing or drain 35 is equated to the medical device. Thus, the dressing straddles the first opening and the medical device emerges from the dressing within the space (See Fig 9; Col 3, line 53 – Col 4, line 10). The intention behind mapping the elements in this way is to show that Antonini teaches pulling a medical device out and away from another element/covering such that it emerges within the space so that the hazardous material remains enclosed within the cover. Therefore, in the combined invention, the sheath of Allen would straddle the first opening so that when the medical device is removed from the patient, it enters the space within the covering. Thus, the combined invention teaches all of the claimed limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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