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 .
Response to Amendment
Applicant's amendments and remarks filed on February 10, 2026 have been entered and considered. Claims 1, 5 and 10 are amended and claims 1 – 20 are pending. In view of Applicant’s amendment, the previously set forth rejection as anticipated by Franz et al. (US 4,389,734) is withdrawn. The invention as currently claimed is not found to be patentable for reasons herein below.
Response to Arguments
Applicant's arguments filed February 10, 2026 have been fully considered but they are not persuasive.
Regarding the double patenting rejection over U.S. Patent No. 12,408,702 (previously provisionally rejected over copending Application No. 18/979,269 (reference application ‘269)), Applicant did not set forth any arguments. The rejection is hereby maintained.
Regarding Applicant’s amendment to claim 1 requiring a skirt portion, the Examiner has withdrawn the previously set forth rejection as anticipated by Franz et al. (US 4,389,734).
Regarding the arguments regarding the rejection as anticipated by Thibodeau (US 2022/0061428), the Examiner has maintained the rejection even in light of the amendments for the following reasons. As shown in Thibodeau Figure 6 provided below and discussed in the rejection of record, Thibodeau teaches a fluid management system including a sleeve member having a first end, a second end, an interior surface, and an exterior surface. The first end of the sleeve member is proximate a distal end of the sleeve of the protective gown and the second end of the sleeve member extends inside of the distal end of the sleeve of the protective gown. A portion of the exterior surface of the sleeve member proximate the second end is in contact with a portion of an interior surface of the sleeve of the gown.
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The first end of the cuff member may be affixed to the first end of the sleeve member and may be foldable onto the portions of the exterior surfaces of both of the sleeve member and the sleeve of the protective gown. The retention member formed by adhering the layers together using an adhesive, sonic or heat welding, sewing, or any other suitable means of adhering the items. Additionally, the cuff member or flap can be secured and impermeable by use of adhesives [0068], [0079], [0010] and [0011]. The Examiner equates the collar and cuff areas affixed by adhesive to Applicant’s “first bonding zone” and “second bonding zone”. Additionally, the end that may be foldable discussed above is equated to Applicant’s “foldable portion” and “skirt” as recited in claim 11. For the limitations of “a skirt portion with an open end extending away from the second bonding zone toward an open edge of the sleeve” in claim 1, the retention member 70 (e.g. rim, band, strip) to secure the cuff ring of the protective glove in place between the interior surface of the cuff member and the exterior surface of one of the sleeve member and the sleeve of the protective gown is equated to Applicant’s “skirt”. It is recommended to further limit the details of the skirt portion.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -18 of U.S. Patent No. 12,408,702 (previously provisionally rejected over copending Application No. 18/979,269 (reference application ‘269)).
Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant claims encompass or are obvious over those of reference application ‘269. While the claims use slightly different language from the instant claims, they recite that the foldable portion of the cuff extends proximally outwardly from the second bonding zone and is configured to fold over and cover the second bonding zone in a folded position and a skirt portion extending in the opposite direction with the same dimensions, structures and materials. One would conclude the claims are overlapping in scope and not patentably distinct.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 11, 14, 16 and 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Thibodeau (US 2022/0061428).
Thibodeau is directed to a fluid management system for a protective gown/glove (Title and [0002]).
As to claim 1, Thibodeau teaches a fluid management system including a sleeve member having a first end, a second end, an interior surface, and an exterior surface. The first end of the sleeve member is proximate a distal end of the sleeve of the protective gown and the second end of the sleeve member extends inside of the distal end of the sleeve of the protective gown. A portion of the exterior surface of the sleeve member proximate the second end is in contact with a portion of an interior surface of the sleeve of the gown. There is a cuff member having a first end, a second end, an interior surface, an exterior surface. The interior surface of the cuff member faces and is moveable with respect to portions of the exterior surface of one or both of the sleeve member and the sleeve of the protective gown to enable the insertion of a cuff ring of the protective glove between interior surface of the cuff member and the exterior surface of one of the sleeve member or the sleeve of the protective gown. The cuff member may include a retention member to secure the cuff ring of the protective glove in place between the interior surface of the cuff member and the exterior surface of one of the sleeve member and the sleeve of the protective gown. The first end of the cuff member may be affixed to the first end of the sleeve member and may be foldable onto the portions of the exterior surfaces of both of the sleeve member and the sleeve of the protective gown. The retention member formed by adhering the layers together using an adhesive, sonic or heat welding, sewing, or any other suitable means of adhering the items. Additionally, the cuff member or flap can be secured and impermeable by use of adhesives [0068], [0079], [0010] and [0011]. The Examiner equates the collar and cuff areas affixed by adhesive to Applicant’s “first bonding zone” and “second bonding zone”. Additionally, the end that may be foldable discussed above is equated to Applicant’s “foldable portion”. For the limitations of “a skirt portion with an open end extending away from the second bonding zone toward an open edge of the sleeve” in claim 1, the retention member 70 to secure the cuff ring of the protective glove in place between the interior surface of the cuff member and the exterior surface of one of the sleeve member and the sleeve of the protective gown is equated to Applicant’s “skirt”.
As to claim 2, Thibodeau teaches, in order to provide secure attachment and preserve impermeability of the garment, the flap 511 can be attached by a seaming cuff weld 513 constructed as described above with reference to techniques including, for example, thermal (e.g., heat welding), chemical (e.g., glues or other adhesives), or mechanical (e.g., adhesive tapes) seaming. The flap 511 can generally be attached at any location along the sleeve 501 suitable for turning the flap 511 down (distally) over the proximal end of a glove 601 (e.g., over the o-ring 602 of a surgical glove) to retain the glove in place and to prevent moisture ingress or egress [0079].
As to claims 3 – 10, Thibodeau teach the configurations and locations of the bonding zones, folding ability and sleeve and cuffs being tubular members in the discussion of the Figures [0064], [0067-0071], see in particular figures 2A, 2B and Figure 6 herein below.
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As to claim 11, Thibodeau teaches a fluid management system including a sleeve member having a first end, a second end, an interior surface, and an exterior surface. The first end of the sleeve member is proximate a distal end of the sleeve of the protective gown and the second end of the sleeve member extends inside of the distal end of the sleeve of the protective gown. A portion of the exterior surface of the sleeve member proximate the second end is in contact with a portion of an interior surface of the sleeve of the gown. There is a cuff member having a first end, a second end, an interior surface, an exterior surface. The interior surface of the cuff member faces and is moveable with respect to portions of the exterior surface of one or both of the sleeve member and the sleeve of the protective gown to enable the insertion of a cuff ring of the protective glove between interior surface of the cuff member and the exterior surface of one of the sleeve member or the sleeve of the protective gown. The cuff member may include a retention member to secure the cuff ring of the protective glove in place between the interior surface of the cuff member and the exterior surface of one of the sleeve member and the sleeve of the protective gown. The first end of the cuff member may be affixed to the first end of the sleeve member and may be foldable onto the portions of the exterior surfaces of both of the sleeve member and the sleeve of the protective gown. The retention member formed by adhering the layers together using an adhesive, sonic or heat welding, sewing, or any other suitable means of adhering the items. Additionally, the cuff member or flap can be secured and impermeable by use of adhesives [0068], [0079], [0010] and [0011]. The Examiner equates the collar and cuff areas affixed by adhesive to Applicant’s “first bonding zone” and “second bonding zone”. Additionally, the end that may be foldable discussed above is equated to Applicant’s “foldable portion” and “skirt” as recited in claim 11.
As to claims 14 and 16, Thibodeau teach the claimed invention above, specifically, Thibodeau teaches that the cuff can be a rubber cuff [0072]. It should be noted that rubber is an elastomeric material. Thibodeau teaches the cuff member 134 overlays and is in contact with the distal end 116 of the impervious surgical gown sleeve 110. Thus, the distal end 116 of the impervious surgical gown sleeve 110 is sandwiched between the exterior surface 122 of sleeve member layer 120 (on the bottom) and interior surface 137 of the impervious member 130 (on the top), forming the three-layer laminate [0060]. The sleeve of the fluid management system may use textiles that may be worn on all extremities of the body including, but not limited to between the hand/wrist and forearm. The sleeve of the fluid management system may be made of knit, woven, non-woven, ultrasonic bonded, welded or heat-sealed material. The sleeve of the fluid management system may be made of natural or synthetic fibers or blends thereof. Each side of the system may be made with or without coatings or films. For example, a laminated material may be used with one side having its own fluid management system, while the outside may be impervious. In all cases, whether formed of natural or synthetic materials, the textile fluid management system may be composed of highly wicking material with high moisture pick-up capability.
The natural or synthetic materials of the sleeve of the sleeve of the fluid management system may include additives, including but not limited to organic material, nano-particles of various types, chemicals, heavy or light metals, waxes, water based anti-microbial(s), including but not limited to chitosan. [0039-0044].
As to claim 19, Thibodeau teaches that the sleeve may optionally include an opening 17 for a user's digit (e.g. a thumb) to secure the wrist opening 14 of sleeve 10 in a position about the user's palm to be well positioned to absorb perspiration [0033]. Additionally, the hand portion can include a thumb loop 507 to provide stability and comfort in the hand area and/or a palm draping 509 to provide moisture management within surgical or other protective gloves by wicking moisture away from the hand area of the wearer. In some embodiments, the thumb loop 507 and palm draping 509 can be formed to provide wicking from the hand while preserving the fit and dexterity afforded by surgical gloves [0078].
Claim Rejections - 35 USC § 103
Claims 12, 13, 15, 17 – 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thibodeau (US 2022/0061428).
As claims 12, 13 and 20, Thibodeau teaches in Figure 5 the cuff portion 360 of the surgical gown sleeve 310 extends a distance X from the rim 370 to its distal end and cuff 380 of wicking layer or sleeve 320 extends the distance X and an additional distance Y from the rim 370 (total distance X+Y) to its distal end. In some cases, X may be different than Y. In one embodiment, X may be equal to Y and they may both equal approximately three (3) inches. In this example, cuff member 360 would extend three (3) inches from rim 370, while cuff portion 380 would extend six (6) inches from rim 370 [0070]. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the width of the first bonding zone, the width of the skirt portion, the width of the foldable portion, the distance between the mid-point of the second bonding zone, the open edge of the sleeve and the mid-point of the second bonding zone to the distal edge of the thumb hole to include the claimed range. One would have been motivated to provide a protective garment with particular dimensions as specified above to create an effective fluid management system that prevents perspiration collecting at the gown/glover interface and prevent fluids from the outside environment penetrating the gown/glove interface and coming into contact with the skin of the person wearing the gown/glove [0032]. Absent a showing of unexpected results, it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II).
As to claims 15 and 17 – 18, Thibodeau teach the claimed invention above, specifically, Thibodeau teaches that the cuff can be a rubber cuff [0072]. Thibodeau teaches the cuff member 134 overlays and is in contact with the distal end 116 of the impervious surgical gown sleeve 110. Thus, the distal end 116 of the impervious surgical gown sleeve 110 is sandwiched between the exterior surface 122 of sleeve member layer 120 (on the bottom) and interior surface 137 of the impervious member 130 (on the top), forming the three-layer laminate [0060]. The sleeve of the fluid management system may use textiles that may be worn on all extremities of the body including, but not limited to between the hand/wrist and forearm. The sleeve of the fluid management system may be made of knit, woven, non-woven, ultrasonic bonded, welded or heat-sealed material. The sleeve of the fluid management system may be made of natural or synthetic fibers or blends thereof. Each side of the system may be made with or without coatings or films. For example, a laminated material may be used with one side having its own fluid management system, while the outside may be impervious. In all cases, whether formed of natural or synthetic materials, the textile fluid management system may be composed of highly wicking material with high moisture pick-up capability.
The natural or synthetic materials of the sleeve of the sleeve of the fluid management system may include additives, including but not limited to organic material, nano-particles of various types, chemicals, heavy or light metals, waxes, water based anti-microbial(s), including but not limited to chitosan. [0039-0044].
Thibodeau teach the claimed invention above but fail to teach the cuff is specifically combinations of a laminate of an elastomeric material sandwiched between two polypropylene films as required by claim 15, laminate of an elastomeric material and one or more layers of a polyolefin film as required by 17 and a laminate of an elastomeric material and fiber layers as required by claim 18.
It would have been obvious to make the cuff with the various claimed laminate combinations because it is a combination of known prior art components with the predictable result of being a suitable cuff material absent a showing of unexpected results. See MPEP 2143.
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 JENNIFER A BOYD whose telephone number is (571)272-7783. The examiner can normally be reached M-F 8 am - 5 pm with alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sri Kumar can be reached at (571) 272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BOYD/Supervisory Patent Examiner, Art Unit 1786