DETAILED ACTION
This is a Final Rejection for Application 19/187,974 filed April 23, 2025. The present application claims the benefit of Chinese Patent Application No. 202510198074.9 filed on February 21, 2025. Claims 1-3 and 6-10 are currently pending.
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
The examiner acknowledges the amendment to claim 1 in the response filed March 20, 2026. The amendment changes the scope of the claim, therefore new grounds of rejection are necessitated by the amendment.
Response to Arguments
Applicant's arguments filed March 20, 2026 have been fully considered but they are not persuasive.
Applicant argues that “[i]n claim 1, the term "staggered" inherently requires a relative displacement between the two layers, such that they are not fully aligned and only partially overlap.”
This argument is unpersuasive as the claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Merriam-Webster dictionary defines the term “stagger” to mean “to arrange in any of various zigzags, alternations, or overlappings of position or time” (See https://www.merriam-webster.com/dictionary/stagger). Since the backing layer 604 and cover 614 are arranged in an overlapping position, they can be called staggered with respect to one another. The specification does not define the term staggered, so claimed terms are given their plain meaning in the art. The argument that the term "staggered" inherently requires a relative displacement between the two layers, such that they are not fully aligned and only partially overlap is a redefining of the term that is not in the original disclosure.
Applicant argues that “[a]s illustrated in FIG. 6 of Shulman reproduced on page 6, the cover 614 of Shulman is provided with vent holes 616, and therefore is not "completely blocking"; but rather allows gas to pass through the cover structure and be discharged.”
The argument is unpersuasive as the claim only requires the soft backing layer to completely block the non-covered area and the cover 614 completely blocks the aperture 612. The vents 616, 618 are not overlapping the aperture 612 so they can be said to block the aperture 612. The claim does not require that the soft blocking layer completely block the non-covered area from gas being discharged however, Shulman teaches this as well in [0031] where after the pressure is relieved or with negative pressure, the cover 614 will typically fall back onto backing layer 604, thereby maintaining a seal around the wound. A seal would be interpreted as blocking discharge of gasses.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., features of the notch) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The only limitations regarding the notch in claim 1 are that one is provided on the inner periphery of the lower backing layer, it is arranged in the overlapping area, and it is connected to the exhaust through hole. Any other features being argued are moot since they do not appear in the claim.
In response to applicant’s argument that Shulman and Bussett have different exhaust mechanisms and structural logic, and there is no motivation to combine them, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the combination that was proposed was to add a vent channel to the aperture 612 of the backing layer 604 of Shulman as taught by Bussett. The provided motivation for doing so was that the vent channel is resistant to blockage from clotting ([0018]) and that the vent channel minimizes the likelihood of the vent hole 14 preventing sealing of the flexible backing sheet 10 against the patient's chest 21 ([0064]). Additionally, it was provided that one of ordinary skill in the art would also recognize that the vent channel would direct any expelled air or fluid from the chest cavity to the one or more vent holes 616, 618 of Shulman and prevent the air or fluid from getting between the hydrogel layer 602 and the backing layer 604. Both references rely on a vent hole to discharge internal fluids while preventing external fluids from entering the underlying wound using similar exhaust mechanics and structural logic. Both references follow the venting path of: wound [Wingdings font/0xE0] aperture [Wingdings font/0xE0] cover lifts to form a gap [Wingdings font/0xE0] gas is vented out of the cover [Wingdings font/0xE0] ambient; which is also the same venting path the present application follows as shown in Fig. 6. In view of the combination, Shulman would function the same while the modification would make the device more resistant to blockage from clotting.
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.
Claim(s) 1-3, 6-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0298578 (Shulman et al.) in view of US 2015/0320919 (Bussett et al.).
Regarding claim 1, Shulman discloses a chest seal (Shulman discloses a wound dressing that provides a tenacious occlusive seal against the skin of a wearer. This wound dressing is capable of use in sealing a wound in the chest. See the embodiment shown in Figs. 6-8.), comprising:
a release layer (1) (Release liner 601);
an adhesive layer (2), wherein a center of the adhesive layer (2) is opened with an exhaust through hole (21) (Hydrogel layer 602 includes a central aperture 610.);
a backing layer (3), wherein the adhesive layer (2) is arranged between the release layer (1) and the backing layer (3) (Backing layer 604, ring-shaped polyester tape 620, and cover 614 combined are interpreted as forming a backing layer. See Fig. 6 and [0027]-[0030]. The hydrogel layer 602 is arranged between the release liner 601 and the combined backing layer.);
the backing layer (3) comprises a lower backing layer (31) and a soft backing layer (32) (Backing layer 604 is interpreted as a lower backing layer while cover 614 is interpreted as a soft backing layer as the cover 614 flexes slightly when in use. See [0031].);
the lower backing layer (31) and the soft backing layer (32) are staggered and form a partial overlapping area (33) (The backing layer 604 and cover 614 are staggered in that they are arranged on top of one another and form a partial overlapping area. See Fig. 6. The backing layer 604 and cover 614 do not overlap at aperture 612 making the overlap a partial overlap.);
the overlapping area (33) comprises a connection area (331) and a non-connection area (332), and the non-connection area (332) is located above the exhaust through hole (21) (The overlapping area between backing layer 604 and cover 614 comprises an area where they are connected by the ring-shaped polyester tape 620 and an area that they are not connected by the tape 620, which is above the central aperture 610.);
the lower backing layer (31) is arranged above the adhesive layer (2) and does not completely block the exhaust through hole (21), a non-covered area (22) is formed between the lower backing layer (31) and the exhaust through hole (21), and the soft backing layer (32) completely blocks the non-covered area (22) (The backing layer 604 is arranged above the hydrogel layer 602 and does not completely block the aperture 610. A non-covered area is formed between the backing layer 604 and the aperture 610 by the aperture 612. The cover 614 completely blocks the aperture 612. See [0029].);
the lower backing layer (31) comprises an inner periphery (311) and an outer periphery (312) (The backing layer 604 comprises an inner periphery and an outer periphery. See Fig. 6.).
Shulman does not disclose the inner periphery (311) is provided with at least one notch (3111); the notch (3111) is arranged in the overlapping area (33); and the notch (3111) is connected to the exhaust through hole (21).
However, Bussett discloses a vented chest wound seal for a penetrating chest wound comprising a hydrogel adhesive sheet 11 and a thin, flexible backing sheet 10. The hydrogel sheet 11 of Bussett is analogous to the backing layer 604 of Shulman in that they are both made of hydrogel and provide apertures for air and fluid from a penetrating chest wound to escape. The backing sheet 10 is analogous to the cover 614 of Shulman in that they both overlap the hydrogel gel layer and provide a vent for air and fluid from a penetrating chest wound to escape while blocking the vent during negative pressures. The hydrogel sheet 11 comprises a vent channel 13 arranged in an overlapping area with the backing sheet 10 that is connected to the chamber 12. See [0058] and Figs. 1-4B.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a vent channel to the aperture 612 of the backing layer 604 of Shulman as taught by Bussett. As a result, Shulman in view of Bussett teaches that it is obvious that the inner periphery (311) is provided with at least one notch (3111) (Shulman teaches that the backing layer 604 comprises an aperture 612 disposed on the inner periphery and Bussett provides support for modifying the aperture to include a vent channel which is interpreted as a notch.);
the notch (3111) is arranged in the overlapping area (33) (Bussett provides support for a vent channel to be added to the aperture in the overlapping area of the hydrogel layer and the cover layer.); and
the notch (3111) is connected to the exhaust through hole (21) (Bussett provides support for the vent channel to be connected to the aperture of backing layer 604 which is connected to the aperture 610.). A skilled artisan would have been motivated to do so because Bussett teaches that the vent channel is resistant to blockage from clotting ([0018]) and that the vent channel minimizes the likelihood of the vent hole 14 preventing sealing of the flexible backing sheet 10 against the patient's chest 21 ([0064]). One of ordinary skill in the art would also recognize that the vent channel would direct any expelled air or fluid from the chest cavity to the one or more vent holes 616, 618 of Shulman and prevent the air or fluid from getting between the hydrogel layer 602 and the backing layer 604. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to chest wound seals comprising one-way mechanisms.
Regarding claim 2, Shulman in view of Bussett discloses the chest seal according to claim 1, wherein the adhesive layer (2) is consistent with the shape of the backing layer (3) (The hydrogel layer 602 is consistent with the shape of the backing layer 604, ring-shaped polyester tape 620, and cover 614 in that they are all round.).
Regarding claim 3, Shulman in view of Bussett discloses the chest seal according to claim 1.
Shulman in view of Bussett does not directly disclose wherein the cross section of the non-covered area (22) is 1/50~4/5 of the cross section of the exhaust through hole (21).
However, the central aperture 612 and the aperture 610 may be different sizes with the range of diameters being from 0.5 to 2.0 inches. See [0029] of Shulman. In the case where in the aperture 610 is the maximum size and the aperture 612 is the minimum size, the non-covered area would be 1/16 the area of the aperture 610 ( (1)2π / (0.25)2π = 1/16 ). This means that the non-covered area can range from 1/16~1/1 of the cross section of aperture 610.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for Shulman in view of Bussett to teach wherein the cross section of the non-covered area (22) is 1/50~4/5 of the cross section of the exhaust through hole (21) (Shulman has support for an overlapping range of values for the cross-section of the non-covered area, which is the aperture 612, of the claimed range.), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Regarding claim 6, Shulman in view of Bussett discloses the chest seal according to claim 1, wherein the connection area (331) is at both ends of the overlapping area (33), and the area of the connection area (331) is greater than 0 (The connection area is interpreted as the area of the ring-shaped polyester tape 620 which is inherently greater than 0.).
Regarding claim 7, Shulman in view of Bussett discloses the chest seal according to claim 1, wherein the notch (3111) is an arc-shaped notch whose edge coincides with an edge of the exhaust through hole (21) (The vent channel added to the aperture 612 of Shulman in view of Bussett is arc-shaped as can be seen in Figs. 2A-2D of Bussett as it is described as terminating in a semi-circular shape in [0037] of Bussett. The edge of the vent channel also coincides with an edge of the chamber 12 in Bussett and is expected to do the same in Shulman.).
Regarding claim 8, Shulman in view of Bussett discloses the chest seal according to claim 1, wherein the soft backing layer (32) is selected from at least one of polyethylene film, polyurethane film, and silicone rubber film (The cover 614 is made of a thermoplastic polyurethane (TPU) film. see [0006].).
Regarding claim 10, Shulman in view of Bussett discloses the chest seal according to claim 1, wherein the adhesive layer (2) is selected from at least one of silicone gel layer, hydrocolloid layer, and hydrogel layer (Hydrogel layer 602 is made of a hydrogel layer.).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0298578 (Shulman et al.) in view of US 2015/0320919 (Bussett et al.), and further in view of US 2013/0317405 (Ha et al.).
Regarding claim 9, Shulman in view of Bussett discloses the chest seal according to claim 1.
Shulman in view of Bussett does not disclose wherein the release layer (1) is selected from at least one of polyethylene (PE) release film, polyethylene terephthalate (PET) release film, oriented polypropylene (OPP) release film, composite release film, glassine release paper, coated release paper, and clay coated kraft (CCK) release paper.
However, Ha discloses a medical wound dressing with a release liner. The release liner is one of supercalendered kraft paper, glassine paper, polyethylene, polypropylene, polyester or composites of any of these materials. See [0096].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the release liner 601 of Shulman to be a polyethylene release film as taught by Ha. As a result Shulman in view of Bussett and Ha teaches that it is obvious that the release layer (1) is selected from at least one of polyethylene (PE) release film, polyethylene terephthalate (PET) release film, oriented polypropylene (OPP) release film, composite release film, glassine release paper, coated release paper, and clay coated kraft (CCK) release paper (Ha provides support for a polyethylene release film.). A skilled artisan would have been motivated to do so because Ha teaches that a polyethylene release film is a suitable material for a release liner used in medical dressings ([0096]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical dressings with release liners.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786