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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/05/2026 has been entered.
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.
Claims 1-7 and 9-12, and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Jutras (US 20190046772 A1) in view of Simmons et al. (US 20150351971 A1).
Regarding Claim 1, Jutras embodiment of Fig 4A-5B, hereinafter Jutras-4, discloses a jacket (protector 100, Fig 4A-5B) for watertight sealing a medical device (catheter 112, Fig 4C), comprising: a flexible envelope (main portion 102, Fig 4A) having a first side (inner side (IS) facing the skin) and an opposing second side (outer side (OS) facing away from the skin); wherein the first side (IS) comprises (i) a first sealing lip (perimeter of cutout/pocket 110 including internal walls of the pocket, Fig 5B) ([0068],[0072]: First side (IS) of main portion 102 wraps around the arm and is in contact with the skin; therefore the perimeter of the pocket 110 in contact with skin upon wrapping seals the device 112) and configured to surround the medical device (102) and (ii) a second sealing lip (waterproof seal portions 108_1-2 + first end 104_1 and second end 104_2, Annotated Fig 1) spaced from the first sealing lip (perimeter of 110 including internal walls of the pocket, Fig 5B)and configured to surround the medical device (112); and the flexible envelope (102) further comprising an envelope contacting sealing end (first end and a second end 104, Fig 4A) that is fixedly connectable to the opposing second side (OS) of the flexible envelope (102).
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Jutras-4 is silent wherein the first sealing lip forms a protrusion on the flexible envelope.
Simmons teaches a device (dressing 100, Fig 1) comprising a first sealing lip (liquid barrier/adhesive strip 104, Fig 1) forms a protrusion on the flexible envelope (liquid resistant sheet 101, Fig 1; [0021]-[0022]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the first sealing lip of device of Jutras with similar protruding sealing lip as taught by Simmons to protect against infection caused by liquid infiltration ([0019]).
Regarding Claim 2, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) surrounds the first sealing lip (perimeter of 110 including internal walls of the pocket, Fig 5B).
Regarding Claim 3, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 is silent wherein the flexible envelope comprises a low elasticity section.
Jutras embodiment of Fig 3A-F, hereinafter Jutras-3, teaches a jacket (catheter protector 100, Fig 3A-3F) wherein the flexible envelope (102, Fig 4A-C) comprises a low elasticity section (U-shaped non-extensible portion 230) ([0055]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the flexible envelope of Jutras-4/Simmons with a similar low elasticity section as the one taught by Jutras-3 to provide stability and holding the parts together ([0055]).
Regarding Claim 4, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the medical device (112) has a height hmd (height of medical device 112), wherein, in a compressed state (wrapped state) of the first sealing lip (perimeter of 110 including internal walls of the pocket, Fig 5B), the first sealing lip (perimeter of 110 including internal walls of the pocket, Fig 5B) has a first sealing lip height (height of the pocket 110) that is larger than the medical device height hmd (height of medical device 112) (Fig 4C; [0070]).
Regarding Claim 5, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) comprises first (waterproof seal portions 108_1-2 + first end 104_1, Annotated Fig 1) and second portions (second end 104_2, Annotated Fig 1).
Regarding Claim 6, Jutras-4/Simmons discloses the jacket according to claim 5. Jutras-4 discloses wherein the first portion (108_1-2 + 104_1, Annotated Fig 1) at least partially runs along an outer edge (upper and lateral edges) of the flexible envelope (102) (waterproof seal portions 108_1-2 runs along lateral edges of the flexible envelope and first end 104_1 runs along the upper edge of the flexible envelope, Annotated Fig 1).
Regarding Claim 7, Jutras-4/Simmons discloses the jacket according to claim 5. Jutras-4 discloses wherein first portion ends (1000 and 1001, Annotated Fig 1) of the first portion (108_1-2 + 104_1, Annotated Fig 1) respectively contact second portion ends (1003 and 1004, Annotated Fig 1) of the second portion (104_2, Annotated Fig 1), wherein the first portion ends (1000 and 1001, Annotated Fig 1) are located on opposing sides relative to a longitudinal axis (Longitudinal axis 1004, Annotated Fig 1) of the flexible envelope (102).
Regarding Claim 9, Jutras-4/Simmons discloses the jacket according to claim 1. However, Jutras-4 is silent wherein the envelope contacting sealing end is made of a material which is more elastic than a material of a remaining portion of the flexible envelope.
Jutras-3 teaches that sections of the flexible envelope can be made of neoprene ([0055]- [0056]). Jutras teaches examples of alternative fastening means ([0056]: “According to a more specific embodiment, the overlapping band of fabric of the waterproof fastener 240 may include a self-adhesive coating such as the pair of rubber bands discussed above, or other adhesive coating that is reusable”). Jutras further teaches that neoprene is more elastic than a material (non-extensible fabric) of a remaining portion (U-shaped non-extensible portion 230) of the flexible envelope (102) ([0055]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the hook and loop fastener contacting sealing of device of Jutras-4/Simmons to be made of neoprene for increased elasticity and will include a pair of waterproof rubber bands having a self-adhesive or reusable coating similar to the ones disclosed by Jutras-3. This is preferred for its simplicity and especially because it does not give rigidity to the sleeve; a remaining portion of the flexible envelope will be made of a similar fabric as the one taught by Jutras-3, to providing stability and holding the parts together ([0055]).
Regarding Claim 10, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein one or both of the first (perimeter of 110, Fig 5B) and second (108_1-2 +104_1-2, Annotated Fig 1) sealing lips are inflatable and/or compressible (when wrapped perimeter or edges of 110 is being compressed against the skin; waterproof sealings 108_1 and 108_2 as well as first and second ends 104 are compressible ([0068]; [0069]).
Regarding Claim 11, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 is silent wherein the first side comprises an adhesive.
Jutras-3 disclose a jacket (catheter protector 100, Fig 3A-3F) and provide examples of fastening means ([0056]: “According to a more specific embodiment, the overlapping band of fabric of the waterproof fastener 240 may include a self-adhesive coating such as the pair of rubber bands discussed above, or other adhesive coating that is reusable”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the hook and loop fastener contacting sealing of device of Jutras-4/Simmons to be made of a pair of waterproof rubber bands having a self-adhesive or reusable coating as taught by Jutras-3. This is preferred for its simplicity and especially because it does not give rigidity to the sleeve ([0055])
Regarding Claim 12, Jutras-4/Simmons discloses the jacket according to claim 1. However, Jutras-4 is silent wherein the flexible envelope is at least partially made of a transparent material.
Jutras-3 teaches a jacket (100, Fig 3D) comprising a flexible envelope (sleeve body 225) having a first side (inner side (IS) facing the skin) and an opposing second side (outer side (OS) facing away from the skin), wherein the flexible envelope (102) is at least partially made of a transparent material. ([0062]: “Alternatively, a transparent window (e.g., a fabric mesh) can be used to insert a non-adhesive label therein.”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the pocket cover of Jutras-4 to be transparent fabric mesh similar to the transparent window disclosed by Jutras-3 to insert a label having information of the patient ([0062]).
Regarding Claim 14, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 is silent wherein s further comprising a humidity sensor.
([0072]: “The fabric may include a variety of sensors such as temperature sensors, humidity sensors.”).
Jutras embodiment of Fig. 7, hereinafter Jutras-7 discloses ([0072]: “The fabric may include a variety of sensors such as temperature sensors, humidity sensors.”; [0074])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Jutras-4/Simmons with similar monitoring system as taught by Jutras-7 for the purpose of detecting parameters such as acidity, salt, fungus, bacteria, and other contaminants that may infect or contaminate the opening receiving the catheter ([0072])
Regarding Claim 15, Jutras-4/Simmons discloses the jacket (protector 100, Fig 4A-5B ) according to claim 1. Jutras-4 discloses a method for watertight sealing a medical device (catheter 112, Fig 4C), comprising: a) mounting a medical device (catheter 112, Fig 4C) on a skin site of an extremity of a user (See Fig 4C) ; b) placing the jacket (protector 100, Fig 4A-5B ) according to claim 1 onto the skin site such that the first sealing lip (perimeter of cutout/pocket 110 including internal walls of the pocket, Fig 5B) ([0068],[0072]: First side (IS) of main portion 102 wraps around the arm and is in contact with the skin; therefore the perimeter of the pocket 110 in contact with skin upon wrapping seals the device 112) and the second sealing lip (waterproof seal portions 108_1 and 108_2 + first end 104_1 and second end 104_2, Annotated Fig 1) surround the medical device (112); and c) wrapping the flexible envelope (102) around the extremity ([0068]) and fixedly connecting the envelope contacting sealing (first end 104) end to the opposing second side (second end 104) (Fig 4C) of the of flexible envelope (102).
Regarding Claim 16, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) comprises a protrusion on the flexible envelope (portions 108 and portions 104 of the second sealing lip protrude from the flexible envelope 102; See Fig 4A-5B).
Regarding Claim 17, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) is configured to completely surround the first sealing lip (perimeter of cutout/pocket 110 including internal walls of the pocket, Fig 5B) when the envelope (102) is wrapped around a user's extremity (Fig 4A-B).
Jutras-4 is silent wherein the first sealing lip forms a protrusion on the flexible envelope.
Simmons teaches a device (dressing 100, Fig 1) comprising a first sealing lip (liquid barrier/adhesive strip 104, Fig 1) forms a protrusion on the flexible envelope (liquid resistant sheet 101, Fig 1; [0021]-[0022]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the first sealing lip of device of Jutras with similar protruding sealing lip as taught by Simmons to protect against infection caused by liquid infiltration ([0019]).
Regarding Claim 18, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) has first (104_1) and second portions (104_2) that are arranged adjacent to each other (adjacent is being interpreted as “near to”; when envelope 102 is wrapped, the first 104_1 and second portions 104_2 are connected near to each other as seen in Fig 4A) and thereby establish a form-fit connection when the envelope (102) is wrapped around a user's extremity (Form fit connection is achieved by wrapping the flexible envelope to fit over the surface of the arm and connect opposite ends 104_1-2 when the envelope (102) is wrapped around a user's extremity).
Regarding Claim 19, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the entire second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) forms a protrusion on the flexible envelope (102) and at least part of the second sealing lip is configured to seal against the user's skin (portions 108_1-2 are configured to seal against the user skin, Fig 4A).
Regarding Claim 20, Jutras-4/Simmons discloses the jacket according to claim 19. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) comprises an interlocking portion (end 104_2, Annotated Fig 1) that interlocks with a first portion (108_1-2 + 104_1, Annotated Fig 1; the first portion comprises portion 104_1 which interlocks with end 104_2) of the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) when the jacket (100) is wrapped around a user's extremity (user hand, Fig 4A; [0071]).
Regarding Claim 21 Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) comprises an interlocking portion (end 104_2) that interlocks with a first portion (108_1-2 + 104_1, Annotated Fig 1; the first portion comprises portion 104_1 which interlocks with end 104_2) of the second sealing lip (108_1-2 + 104_1-2, Annotated Fig 1) when the jacket (100) is wrapped around a user's extremity (user hand, Fig 4A; [0071]).
Regarding Claim 22 Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 discloses wherein the envelope contacting sealing end (104_2, Annotated Fig 1) and opposing second side (OS) of the flexible envelope (102) substantially overlap when the jacket (100) is wrapped around a user's extremity (user hand, Fig 4A; [0071]; please see overlap region in Fig 4A; both end 104_2, annotated Fig 1 and Outer Surface of portion 104_1 have an overlapping area substantially enough to secure jacket after it is wrapped).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jutras (US 20190046772 A1) in view of Simmons et al. (US 20150351971 A1) in further view of Furman (US 20080208130 A1).
Regarding Claim 8, Jutras-4/Simmons discloses the jacket according to claim 5. Jutras-4 discloses wherein the first portion (108_1-2 + 104_1, Annotated Fig 1) is a skin contacting portion and the second portion (104_2, Annotated Fig 1) is an interlocking portion (when wrapped section where 104_2 interlock to 104_1, Fig 4A) and configured to be arranged next to the first portion (108_1-2 + 104_1, Annotated Fig 1) (Fig 4A), thereby establishing a form-fit connection (form fit connection is achieved by the wrapping the flexible envelope to fit over the surface of the arm and connect opposite ends 104_1-2).
Jutras-4 is silent wherein the interlocking portion is configured to contact the opposing second side (OS) of the flexible envelope (102).
Furman teaches a jacket (protective sleeve 20, Fig 3) comprising an interlocking portion (fastening means 23, Fig 3) is configured to contact the opposing second side (OS) of the flexible envelope (portion comprising other fastening means 23 of sleeve 20 outer surface).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Jutras-4/Simmons with similar fastening means on the outer surface of the jacket as taught by Furman for the purpose of improving patient comfort and be used by patients of larger size ([0021-0022]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jutras (US 20190046772 A1) in view of Simmons et al. (US 20150351971 A1) in further view of Weiser (US 20040204740 A1).
Regarding Claim 13, Jutras-4/Simmons discloses the jacket according to claim 1. Jutras-4 is silent wherein the first side is at least partially colored with a first color and the opposing second side is at least partially colored with a second color different from the first color.
Weiser teaches a jacket (closure device, Fig 1) comprising a flexible envelope (base strip 1, Fig 1) having a first side (protective tape 14, Fig 1) and an opposing second side (protective tape 16, Fig 1), wherein the first side (14) is at least partially colored with a first color and the opposing second side (16) is at least partially colored with a second color different from the first color ([0046]: “each of the tape elements may be color coded or otherwise identified to indicate the order of removal (…) different colors or transparency tints may be used.”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the pocket cover located on second side of device of Jutras-4/Simmons with a transparency tint as taught by Weiser to provide visual identification of this element and visibility of the medical device. The pocket cover will have a different color code from the first side to provide user with identification means for inner and outer surface of the device to make placement of jacket easier and improve user experience ([0046]).
Response to Arguments
Applicant's arguments filed claims 1-22 have been fully considered but they are not persuasive.
Applicant submits that portions 104 are used to adhere the two ends of the bandage together and are not part of a second sealing lip as claimed. Thus, Jutras does not disclose a second sealing lip as claimed. Applicant further submits that the recitation of the second sealing lip configured to surround the first sealing lip is also not disclosed by Jutras. Examiner respectfully disagrees.
Claim 1 limitation requires: (…) “a second sealing lip spaced from the first sealing lip and configured to surround the medical device”
Jutras discloses a second sealing lip (waterproof seal portions 108_1-2 + first end 104_1 and second end 104_2, Annotated Fig 1) spaced from the first sealing lip (perimeter of 110 including internal walls of the pocket, Fig 5B) and configured to surround the medical device (112)(Note: the waterproof seal portions 108_1-2 + first end 104_1 and second end 104_2, Annotated Fig 1 surrounds pocket 110 in both configurations extended and wrapped, please see Fig 4A-5B).
Sealing lip is being interpreted as one or more protrusions configured to seal. Specifically, the sealing lip ends 104 protrudes from the envelope 102 a certain distance and assist the sealing function of the device 100 because the attachment of ends 104 is needed to compress portions 108 against the skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783