SoDETAILED 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 group I in the reply filed on 5/11/2026 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/2026. The proper status indicator of “withdrawn” has not been given to claims 13-15. Claims 13-15 should be given the status indicator of withdrawn. See MPEP 714(II)(c) and 37 CFR 1.121.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/16/2024, 3/6/2025, and 5/28/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 1 recites “A sheath for enshrouding a non-sterile medical device, comprising”. Examiner suggests replacing “A sheath for enshrouding a non-sterile medical device, comprising” in line 1 of claim 1 with “A sheath for enshrouding a non-sterile medical device, the sheath comprising” to put the claim in clearer form as the components listed in claim 1 are of the sheath, not the non-sterile medical device.
Claim 12 objected to because of the following informalities:
Line 1-3 recites “wherein the cap engages the aperture in one of a threadable engagement, press-fit engagement, interference fit engagement, snap-fit engagement to releasably secure”. This is grammatically incorrect. Examiner suggests replacing “wherein the cap engages the aperture in one of a threadable engagement, press-fit engagement, interference fit engagement, snap-fit engagement to releasably secure” in line 1-3 of claim 12 with “wherein the cap engages the aperture in one of a threadable engagement, a press-fit engagement, an interference fit engagement, or a snap-fit engagement to releasably secure”.
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 1-12 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 2-3 recites “an opening at a first end”. It is unclear what structure the opening at the first end is of. It is unclear if the opening at a first end is of the body, the elongate cavity, or the sheath. For examination purposes Examiner construes “an opening at a first end” to be “an opening at a first end of the body”. Examiner suggests replacing “an opening at a first end” in line 2-3 of claim 1 with “an opening at a first end of the body”.
Line 4 recites “a second end of the body”. As noted above, it is unclear if the body has a first end. Introducing a second end of the body before introducing a first end of the body renders the scope of the claim unclear, since it is unclear if a first end of the body would also be required. Examiner suggests addressing the issue with line 2-3 of claim 1 above to introduce a first end of the body.
Line 6 recites “therethrough”. It is unclear if therethrough refers to the port, the aperture, or the sheath. For examination purposes Examiner construes “therethrough” to be “through the port”. Examiner suggests replacing “therethrough” in line 6 of claim 1 with “through the port”.
Examiner notes claims 2-12 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 4,
Line 1-2 recites “wherein the body is configured to pass through the opening at the first end”. As noted above, it is unclear if the first end is a structure of the body. If the first end is a structure of the body, it is unclear how the body which includes the first end would be configured to pass through the opening at the first end. For examination purposes Examiner construes “wherein the body is configured to pass through the opening at the first end” to be “wherein a portion of the body is configured to pass through the opening at the first end”. Examiner suggests clarifying the issues regarding the first end above and specifying which part/portion of the body is configured to pass through the opening at the first end.
In regard to claim 9,
The term “relatively” in line 2 of claim 9 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much more rigid the second material is than the first material. It is unclear the scope “relatively more rigid”. For examination purposes Examiner construes “relatively more rigid” to mean any value of rigidity higher than the rigidity of the first material.
Examiner notes claim 10 is similarly rejected by virtue of its dependency on claim 9.
In regard to claim 11,
Line 3 recites “therebetween”. It is unclear if “therebetween” refers to between the cap and the aperture or between the aperture and the non-sterile medical device or between the aperture and a different structure. For examination purposes Examiner construes “therebetween” to be between the cap and the aperture. Examiner suggests replacing “therebetween” in line 3 of claim 11 with “between the cap and the aperture”.
In regard to claim 12,
Line 3 recites “therebetween”. It is unclear if “therebetween” refers to between the cap and the aperture or between the aperture and the non-sterile medical device or between the aperture and a different structure. For examination purposes Examiner construes “therebetween” to be between the cap and the aperture. Examiner suggests replacing “therebetween” in line 3 of claim 12 with “between the cap and the aperture”.
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.
Claims 1, 3, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valdez (U.S. PG publication 20220054217).
In regard to claim 1,
Valdez discloses a sheath (figure 3A, item 310) for enshrouding a non-sterile medical device (Examiner notes “for enshrouding a non-sterile medical device” is a functional limitation. The non-sterile medical device is not positively required by the claim. The sheath is fully capable of the recited function due to its structure as supported by figure 3A), comprising:
a body (see figure 3A wherein the sleeve 310 includes a body that extends between item 320a and 320b) defining an elongate cavity (see figure 3A) and communicating with an opening at a first end (see figure 3A wherein the first end is construed as the end which contains an opening and closing element 320b); and
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a port (figure 3A above wherein item 330 and the opening which item 330 covers is construed as the port) disposed at a second end of the body opposite the first end (see figure 3A above), the port including an aperture (opening which item 330 covers) and a cap (figure 3A, item 330) selectively removable from the aperture (see position in figure 3A as compared to figure 3B; paragraph [0077]) to allow a portion of a sterile medical device to pass therethrough (Examiner notes “to allow a portion of a sterile medical device to pass therethrough” is a functional limitation. A portion of a sterile medical device is not positively required by the claim. The port is fully capable of the recited function due to its structure as item 330 can be opened to allow a portion of a sterile medical device to pass therethrough; paragraph [0077] and [0038]).
In regard to claim 3,
Valdez discloses the sheath according to claim 1, wherein the body includes a sterile surface on a first side (Examiner notes the first side is construed as the bottom side of item 310, opposite of flap 330, which is placed under the medical devices and which is closest to the arm of the patient; Examiner notes an inside surface of item 310 on the first side is a sterile surface as supported by paragraph [0041] and [0044]) and a non-sterile surface on a second side (Examiner notes the second side is construed as the top side of item 310 which flap 330 is on and which is placed over the top of the medical devices; Examiner notes the outside surface on the second side is a non-sterile surface), opposite the first side (see figure 3A and figure 8B below).
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In regard to claim 11,
Valdez discloses the sheath according to claim 1, wherein one or both of the cap and the aperture of the port includes an adhesive layer (resealable surface; paragraph [0077]) configured to releasably secure the cap over the aperture and provide a seal therebetween (paragraph [0077]).
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.
Claims 2, 9-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Valdez (U.S. PG publication 20220054217) further in view of Leahy (U.S. Patent 5813409).
In regard to claim 2,
Valdez discloses the sheath according to claim 1, wherein the body is formed of a first material that is a flexible material (paragraph [0004]).
Valdez is silent as to wherein the body is formed of a first material that is a flexible, gas-impervious material.
Leahy teaches wherein the body (figure 1, item 12) is formed of a first material that is a flexible, gas-impervious material (column 3, line 14-15).
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 Valdez to include wherein the body is formed of a first material that is a flexible, gas-impervious material, as taught by Leahy, for the purpose of maintaining an isolated and aseptic environment (column 2, line 18-24 of Leahy).
In regard to claim 9,
Valdez in view of Leahy teaches the sheath according to claim 2, wherein the port is formed of a second material that is different than the first material (paragraph [0069] of Valdez).
Valdez in view of Leahy is silent as to wherein the port is formed of a second material that is relatively more rigid than the first material.
Leahy teaches wherein the port (figure 3, item 26) is formed of a second material (material of item 26c) that is relatively more rigid than the first material (column 3, line 51-54).
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 Valdez in view of Leahy to include wherein the port is formed of a second material that is relatively more rigid than the first material, as taught by Valdez, for the purpose of providing tear resistance (column 3, line 51-54 of Leahy) and as Valdez supports that the second material can be different than the first material (paragraph [0069] of Valdez).
In regard to claim 10,
Valdez in view of Leahy teaches the sheath according to claim 9, wherein the second material includes a plastic, polymer, rubber, or silicone rubber (paragraph [0037] of Valdez, [0046]-[0049] of Valdez).
Further, it would have been an obvious matter of design choice to modify Valdez in view of Leahy to include wherein the second material includes a plastic, polymer, rubber, or silicone rubber since applicant has not disclosed that having the second material specifically include a plastic, polymer, rubber, or silicone rubber solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the second material includes a plastic, polymer, rubber, or silicone rubber, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 12,
Valdez discloses the sheath according to claim 1, wherein the cap engages the aperture to releasably secure the cap over the aperture and provide a seal therebetween (paragraph [0077]).
Valdez is silent as to wherein the cap engages the aperture in one of a threadable engagement, press-fit engagement, interference fit engagement, snap-fit engagement to releasably secure the cap over the aperture and provide a seal therebetween.
Leahy teaches wherein the cap (figure 3, item 24C) engages the aperture (opening 24a which cap is received in) in one of a threadable engagement, press-fit engagement, interference fit engagement, snap-fit engagement (snap-fit engagement; column 3, line 41-48) to releasably secure the cap over the aperture and provide a seal therebetween (Examiner notes “to releasably secure the cap over the aperture and provide a seal therebetween” is a functional limitation. The snap-fit engagement is fully capable of the recited function due to its structure; column 3, line 41-48).
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 Valdez to substitute wherein the cap engages the aperture in one of a threadable engagement, press-fit engagement, interference fit engagement, snap-fit engagement to releasably secure the cap over the aperture and provide a seal therebetween of Leahy in place of the cap and aperture engagement of Valdez, as taught by Leahy, because the substitution is a simple substitution that would yield the same predictable result of releasably securing the cap over the aperture and provide a seal therebetween (see column 3, line 41-48 of Leahy and paragraph [0077] of Valdez). Furthermore, Valdez discloses modifications can be made (paragraph [0115] of Valdez).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez (U.S. PG publication 20220054217) and further as evidenced by Haskin (U.S. PG publication 20080296193).
In regard to claim 4,
Valdez discloses the sheath according to claim 3, wherein the body is configured to pass through the opening at the first end to transition the body between a first configuration where the non-sterile surface is disposed outwards, and a second configuration where the sterile surface is disposed outwards (Examiner notes “configured to pass through the opening at the first end to transition the body between a first configuration where the non-sterile surface is disposed outwards, and a second configuration where the sterile surface is disposed outwards” is a functional limitation. The body is fully capable of the recited function due to its structure and material properties as supported by paragraph [0060] and figure 8B, 8C, and 8E and further as evidenced by Haskin which supports that a flexible body is configured to pass through the opening at the first end to transition the body between a first configuration where the non-sterile surface is disposed outwards, and a second configuration where the sterile surface is disposed outwards, see paragraph [0051]-[0053] of Haskin).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Valdez (U.S. PG publication 20220054217) further in view of Lloyd (U.S. PG publication 20150053582).
In regard to claim 5,
Valdez discloses the sheath according to claim 3.
Valdez is silent as to further including a first adhesive layer disposed on at least a portion of the first side and configured to secure the sheath to a portion of a sterile field.
Lloyd teaches further including a first adhesive layer (figure 3B, item 321; paragraph [0061]: wherein the adhesive tape has a removable backing) disposed on at least a portion of the first side (see figure 3B) and configured to secure the sheath to a portion of a sterile field (Examiner notes “configured to secure the sheath to a portion of a sterile field” is a functional limitation. The first adhesive layer is fully capable of the recited function due to its structure; paragraph [0061]-[0062]).
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 Valdez to include a first adhesive layer disposed on at least a portion of the first side and configured to secure the sheath to a portion of a sterile field and the removable backing, as taught by Lloyd, for the purpose of enabling adhesion to a surface (paragraph [0061]-[0062] of Llyod).
In regard to claim 6,
Valdez in view of Lloyd teaches the sheath according to claim 5.
Valdez in view of Lloyd is silent as to wherein the first adhesive layer extends from the port to the opening at the first end.
It would have been an obvious matter of design choice to modify Valdez in view of Lloyd to include wherein the first adhesive layer extends from the port to the opening at the first end since applicant has not disclosed that having wherein the first adhesive layer extends from the port to the opening at the first end solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the first adhesive layer extends from the port to the opening at the first end, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 7,
Valdez in view of Lloyd teaches the sheath according to claim 5, further including a release layer (removable backing; paragraph [0061] of Lloyd, see analysis of claim 5 above) disposed on the first adhesive layer (paragraph [0061] of Lloyd, see analysis of claim 5 above).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez (U.S. PG publication 20220054217).
In regard to claim 8,
Valdez discloses the sheath according to claim 3.
The first embodiment of Valdez is silent as to further including a second adhesive layer disposed on at least a portion of the second side and configured to releasably secure a portion of the sheath to the non-sterile medical device.
A second embodiment of Valdez teaches a second adhesive layer (figure 13A, item 1314) disposed on at least a portion of the second side (see figure 13A) and configured to releasably secure a portion of the sheath to the non-sterile medical device (Examiner notes “configured to releasably secure a portion of the sheath to the non-sterile medical device”. The second adhesive layer is fully capable of the recited function due to its structure as supported by paragraph [0088] and [0059]).
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 Valdez to include a second adhesive layer disposed on at least a portion of the second side and configured to releasably secure a portion of the sheath to the non-sterile medical device, as taught by the second embodiment of Valdez, for the purpose of safety and convenience (paragraph [0088] and [0059] of Valdez).
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.
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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.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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