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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 3/20/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim(s) 1, 3, 7-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mullet et al. (US 8,597,254; “Mullet”).
Regarding claim 1, Mullet teaches a device (the protective sleeve of Mullet, col. 1, lines 53-67, col. 2, lines 11-18, col. 2, lines 35-54, see Fig. 9C below), comprising:
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- a flexible sleeve sized to receive and enclose a set of one or more medical lines connected to a patient (col. 2, lines 11-18, col. 2, lines 35-54), the flexible sleeve having first and second ends and a flexible body extending between the first and second ends (col. 1, lines 53-67, col. 2, lines 11-18, col. 2, lines 35-54, see annotated Fig. 9C below for reference to the sleeve, the first and second ends and the flexible body, medical lines, respectively, meeting the claimed limitations)
- the flexible sleeve including one or more antimicrobial agents disposed throughout an entire length of the flexible body (col. 5, lines 63-67, and col. 6, lines 1-3, the sleeve is made of material comprising antimicrobial agents, i.e., having antimicrobial agents throughout the entire sleeve);
- a first closing element disposed at the first end of the flexible sleeve, the first closing element configured to selectively open and close the first end of the flexible sleeve (col. 2, lines 11-18, col. 2, lines 35-54, see annotated Fig. 9C above for reference to the first closing element and the second closing element, respectively, both are of releasable/reclosable closures, i.e., selectively open and close); and
- a second closing element disposed at the second end of the flexible sleeve, the second closing element configured to selectively open and close the second end of the flexible sleeve (col. 2, lines 11-18, col. 2, lines 35-54, see annotated Fig. 9C above for reference to the first closing element and the second closing element, respectively, both are of releasable/reclosable closures, i.e., selectively open and close),
- the first and second closing elements configured to open the first and second ends of the flexible sleeve such that the flexible sleeve can be placed around the set of medical lines (col. 2, lines 11-18, col. 2, lines 35-54, see annotated Fig. 9C above for reference to the first closing element and the second closing element, respectively, both are of releasable/reclosable closures, i.e., configured to open the first and second ends of the flexible sleeve such that the flexible sleeve can be placed around the set of medical lines, meeting the claimed limitations),
- the first and second closing elements configured to close the first and second ends of the flexible sleeve around the set of medical lines at the first and second ends of the flexible sleeve such that the flexible sleeve is configured to protect the set of medical lines from contaminants (col. 2, lines 11-18, col. 2, lines 35-54, see annotated Fig. 9C above for reference to the first closing element and the second closing element, respectively, both are of releasable/reclosable closures, i.e., configured to close the first and second ends of the flexible sleeve around the set of medical lines at the first and second ends of the flexible sleeve such that the flexible sleeve is configured to protect the set of medical lines from contaminants, meeting the claimed limitations).
Regarding claim 3, Mullet teaches as in one of its embodiments that the one or more antimicrobial agents are embedded in the flexible sleeve (col. 5, lines 63-67, and col. 6, lines 1-3; Mullet teaches as in one of its embodiments that the sleeve is made of material comprising antimicrobial agents, i.e., having antimicrobial agents embedded in/throughout the entire sleeve, meeting the claimed limitations).
Regarding claim 7, Mullet teaches as in one of its embodiments that its sleeve has an optical transmittance of at least about 50% (col. 5, lines 65-67; Mullet teaches as in one of its embodiments that its sleeve is made of transparent material, transparent plastic, i.e., having an optical transmittance of almost 100% because the material is transparent, meeting the claimed limitations).
Regarding claim 8, Mullet teaches as in one of its embodiments that its sleeve is tinted with a prescribed color to indicate at least one of a type of the set of medical lines disposed therein or a characteristic of the patient (col. 6, lines 16-19, Mullet teaches as in one of its embodiments that its protective sleeve formed of or comprising a material that is coded based on color that conforms with a predetermined coding standard to enable ready identification of the lines enclosed therein), meeting the claimed limitations.
Regarding claim 10, Mullet teaches as in one of its embodiments, that the first and second closing elements includes a resealable adhesive element (resealable adhesive element of Velcro closure 6) configured to adhere to a surface of the flexible sleeve to close around the set of medical lines (col. 9, lines 47-57, also see Fig. 9B), meeting the claimed limitations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 4-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mullet as applied to claim 1 above, further in view of Skroski et al. (US 2017/0367779; “Skroski”).
The limitations of claim 1 are taught by Mullet as discussed above.
Regarding claim 2, Mullet teaches its sleeve may be of suitable antimicrobial agent (col. 5, lines 63-67, and col. 6, lines 1-3), but Mullet does not teach using the specific antimicrobial agent as instantly claimed.
In the same field of protective cover for medical device, Skroski teaches a barrier for medical scopes (para [0003]), of which the barrier can be an antimicrobial, antiviral, antipathogenic or antibacterial in order to reduce or eliminate contamination of the scope during use of the device (para [0046]). Skroski teaches its barrier includes suitable antimicrobial materials being disposed throughout the entirety of the barrier material in order to protect the entirety of the covered surface to reduce the amount of microbes, viruses, pathogens, germs, diseases, or bacteria on the stethoscope head before patient use (para [0057]). Skroski teaches suitable antimicrobial materials includes silver, copper, zinc, cobalt (para [0053]).
It would have been obvious to one of ordinary skill in the art to modify the device of Mullet in view the teachings of Skroski, to select and include in the flexible sleeve of Mullet with the suitable antimicrobial agent such as silver as taught by Skroski, to provide the device with desired antimicrobial property, which would have predictably arrived at a satisfactory device that is the same as instantly claimed. One of ordinary skill would have understood how to modify and choose suitable additives for intended use. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.05.
Regarding claim 4, Mullet teaches its sleeve may be of suitable antimicrobial agent (col. 5, lines 63-67, and col. 6, lines 1-3), but Mullet does not teach the antimicrobial agent as coat/coating, as instantly claimed.
In the same field of protective cover for medical device, Skroski teaches a barrier for medical scopes (para [0003]), of which the barrier can be an antimicrobial, antiviral, antipathogenic or antibacterial in order to reduce or eliminate contamination of the scope during use of the device (para [0046]). Skroski teaches its barrier includes suitable antimicrobial materials being disposed throughout the entirety of the barrier material in order to protect the entirety of the covered surface to reduce the amount of microbes, viruses, pathogens, germs, diseases, or bacteria on the stethoscope head before patient use (para [0057]). Skroski teaches the antimicrobial material may be coated or sprayed on the surface of the barrier (para [0057]).
It would have been obvious to one of ordinary skill in the art to modify the device of Mullet in view the teachings of Skroski, to coat/spray suitable antimicrobial agent on either an inner and/or outer surface of the flexible sleeve of Mullet, to provide the device with further improved antimicrobial property, which would have predictably arrived at a satisfactory device that is the same as instantly claimed.
Regarding claim 5, Mullet teaches its sleeve may be of suitable antimicrobial agent (col. 5, lines 63-67, and col. 6, lines 1-3), of which the (first) antimicrobial agent is embedded in the flexible sleeve. But Mullet does not teach the inclusion a second antimicrobial agent as coat/coating, as instantly claimed.
In the same field of protective cover for medical device, Skroski teaches a barrier for medical scopes (para [0003]), of which the barrier can be an antimicrobial, antiviral, antipathogenic or antibacterial in order to reduce or eliminate contamination of the scope during use of the device (para [0046]). Skroski teaches its barrier includes suitable antimicrobial materials being disposed throughout the entirety of the barrier material in order to protect the entirety of the covered surface to reduce the amount of microbes, viruses, pathogens, germs, diseases, or bacteria on the stethoscope head before patient use (para [0057]). Skroski teaches the antimicrobial material may be coated or sprayed on the surface of the barrier (para [0057]).
It would have been obvious to one of ordinary skill in the art to modify the device of Mullet in view the teachings of Skroski, to coat/spray suitable (second) antimicrobial agent on either an inner and/or outer surface of the flexible sleeve of Mullet (i.e., of which the sleeve of Mullet is of antimicrobial agent/first antimicrobial agent, that is, the (first) antimicrobial agent is embedded in the flexible sleeve), in particular, to provide a different antimicrobial agent than the antimicrobial agent that is of the sleeve, to provide the device with further improved and enhanced antimicrobial property, which would have predictably arrived at a satisfactory device that is the same as instantly claimed.
Regarding claim 9, Mullet teaches its sleeve may be of suitable plastic material (col. 5, lines 65-67), but Mullet does not teach using the specific material as instantly claimed.
In the same field of protective cover for medical device, Skroski teaches a barrier for medical scopes (para [0003]). Skroski teaches suitable materials for its protective barrier/sheath including rubber, polyethylene-vinyl acetate copolymer (para [0054]), meeting the claimed material limitations of claim 9.
It would have been obvious to one of ordinary skill in the art to modify the device of Mullet in view the teachings of Skroski, to select the suitable material for the sleeve of Mullet, such as rubber and/or polyethylene-vinyl acetate copolymer as taught by Skroski as suitable for making protective barrier/sheath for use in medical applications, (para [0003] [0054]), which would have predictably arrived at a satisfactory device that is the same as instantly claimed. One of ordinary skill would have understood how to modify and choose suitable material for intended use. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.05.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mullet as applied to claim 1 above, further in view of Muto (US 4,392,853).
The limitations of claim 1 are taught by Mullet as discussed above.
Regarding claim 6, Mullet does not teach the inclusion of an adhesive flange, as instantly claimed.
In the same field of protective sleeve, Muto teaches a flexible sleeve (67) having a first and a second closing elements and includes an adhesive flange (see Fig. 7) (see Fig. 7, for reference to the adhesive flange, i.e., the base flange 83 with adhesive layer 86 provided thereon) that is capable to be attached to a dressing overlaying an insertion site and encircle the insertion site, to keep the incision and indwelling device free of contamination (col. 5, lines 20-28).
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It would have been obvious to one of ordinary skill in the art to modify the device of Mullet in view the teaching of Muto, to include at one of the first and the second closing element with an adhesive flange as taught by Muto, to attach the device to a dressing overlaying an insertion site and encircle the insertion site, for the benefit of keeping the incision and indwelling device free of contamination as taught by Muto (col. 5, lines 20-28), which would have predictably arrived at a satisfactory device that is the same as instantly claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN LAN whose telephone number is (571)270-3687. The examiner can normally be reached Monday - Friday 7AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 5712728935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN LAN/Primary Examiner, Art Unit 1782
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