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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/02/2026 has been entered.
Status of Claims
The amendment filed 09/02/2026 has been entered. Claims 1-5, 7-21 are pending in the application.
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 7-8 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.
Claim 7 recites “a first adhesive segment” in line 3. It is unclear whether this is the same or different adhesive segment than the one recited in claim 1. For the sake of examination, the limitation will be interpreted as reciting “the first adhesive segment”.
Claim 8 is rejected as depending from a rejected claim.
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 1-5, 7-10, 12-14, 18-21 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 Fenwick (US 2005/0061330).
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 comprising a sheet having first and second sheet portions that substantially overlie one another to at least partially enclose a space therebetween, the cover 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, the cover further comprising first and second adhesive segments disposed between the first and second sheet portions and spaced from one another, wherein a gap is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends
Antonini teaches a cover (10, Fig 1) comprising a sheet having first (13, Fig 2) and second (14, Fig 2) sheet portions that substantially overlie on another to at least partially enclose a space therebetween, the cover 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), the cover further comprising adhesive segments (19, 20, 21, 25, Fig 1) disposed between the first and second sheet portions (Col 2, line 67 – Col 3, line 7)
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).
The modified invention of Allen and Antonini disclose all of the elements of the invention as discussed above, however, is silent regarding the cover further comprising first and second adhesive segments disposed between the first and second sheet portions and spaced from one another, wherein a gap is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends
Fenwick teaches an analogous cover comprising first and second adhesive segments (36, Fig 2, the fastener can include adhesive as detailed in Para 0022) disposed between the first and second sheet portions (20, 22, Fig 2) and spaced from one another, wherein a gap (40, Fig 3) is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends (Para 0021).
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 adhesive segments to include one or more gaps as taught by Fenwick in order to allow the arrangement of the tube(s) in any number of desirable configurations (Para 0021).
Regarding Claim 2, the modified invention of Allen, Antonini, and Fenwick 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, Antonini, and Fenwick discloses the sheet is folded along a fold line (15, Fig 1 -Antonini) such that the first and second sheet portions substantially overlie one another (Col 2, lines 52-67 -Antonini).
Regarding Claim 4, the modified invention of Allen, Antonini, and Fenwick discloses the cover (10, Fig 1 -Antonini) comprising an adhesive system including the first and second adhesive segments, the adhesive system bonding 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, Antonini, and Fenwick 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 7, the modified invention of Allen, Antonini, and Fenwick 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 as modified by Fenwick to have gaps) 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, Antonini, and Fenwick 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, Antonini, and Fenwick 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, Antonini, and Fenwick 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, Antonini, and Fenwick 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 first and second 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, the cover further comprising a first adhesive segment and a second adhesive segment disposed between the first and second sheet portions and spaced from one another, wherein a gap is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends 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 first (13, Fig 2) and second (14, Fig 2) 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, the cover further comprising adhesive segments (19, 20, 21, 25, Fig 1) disposed between the first and second sheet portions (Col 2, line 67 – Col 3, line 7) 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).
The modified invention of Allen and Antonini disclose all of the elements of the invention as discussed above, however, is silent regarding the cover further comprising first and second adhesive segments disposed between the first and second sheet portions and spaced from one another, wherein a gap is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends
Fenwick teaches an analogous cover comprising first and second adhesive segments (36, Fig 2, the fastener can include adhesive as detailed in Para 0022) disposed between the first and second sheet portions (20, 22, Fig 2) and spaced from one another, wherein a gap (40, Fig 3) is defined between the first and second sheet portions and the first and second adhesive segments, wherein the gap is a confined opening that is devoid of adhesive and provides access into the space and defines a substantially linear path through which the medical device extends (Para 0021).
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 adhesive segments to include one or more gaps as taught by Fenwick in order to allow the arrangement of the tube(s) in any number of desirable configurations (Para 0021).
Regarding Claim 14, the modified invention of Allen, Antonini, and Fenwick 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), which included the first and second adhesive segments, provided on the sheet assembly (Col 3, lines 46-52 -Antonini).
Regarding Claim 18, the modified invention of Allen, Antonini, and Fenwick 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, Antonini, and Fenwick 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, Antonini, and Fenwick 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).
Regarding Claim 21, the modified invention of Allen, Antonini, and Fenwick discloses each of the first and second adhesive segments (20, 25, Fig 1 -Antonini as modified by Fenwick) is disposed adjacent to and spaced from respective edges of the first and second sheet portions (See Fig 2 of Fenwick wherein the adhesive segments 36 are spaced from the edges of the sheet portions).
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 Fenwick (US 2005/0061330) and further in view of Serivens (US 4,033,341).
Regarding Claim 11, the modified invention of Allen, Antonini, and Fenwick discloses the cover comprises an adhesive system (29, Fig 2 -Antonini) that affixes the cover adjacent to a target site (Col 3, lines 43-45 -Antonini), 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, Antonini, and Fenwick 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 Fenwick discloses 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, the modified invention of Allen, Antonini, and Fenwick discloses 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 09/02/2026, on pages 6-7, regarding Allen and Antonini failing to teach the amended limitation have been fully considered but are moot in view of the current rejection that relies on Fenwick to teach the new limitations.
Conclusion
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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