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 .
Status of Claims
As directed by the amendment filed on 20 February 2025: claim(s) 1-15 have been amended.
Claim Objections
Claims 2-3 & 9-10 are objected to because of the following informalities:
Each claim should begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). The claim recites “a.”, “b.”… “h.” which is recommended to be replaced with “a)”, “b)”… “h)”.
Appropriate correction is required.
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 1-15 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.
Claims 1 & 12 recite the limitation " in particular". The phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claim(s) is/are rejected due to dependency upon a rejected claim.
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.
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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seddon et al. (US 20230338194 A1) in view of Cotton (WO 2020104818 A1).
Regarding Claim 1, Seddon discloses a flexible connector ("bridge 160" [0066]; FIG. 8) which can be coupled to a device for treating a wound and removing a fluid from said wound by means of the use of a negative pressure system ("fluidly couple the dressing 110 to the negative-pressure source 105" [0066]), the connector comprising:
a deformable tubular cover ("liquid barrier formed from two layers" [0100]) having a first end which can be connected to a plaster ("coupled to the dressing 110" [0105]) to be applied to said wound ([0084]) and a second end opposite the first end, wherein the flexible connector is configured to be coupled to a negative pressure source ("flexible fluid conductor" [0095]; FIG. 2) such that the fluid flows from the first end to the second end inside the tubular cover when the negative pressure is applied ("bridge 160 may fluidly couple the dressing 110 to the negative-pressure source 105" [0066] & [0099]; FIG. 1), and
an anti-collapse element ("spacer layer 375" [0106]; FIG. 3B) placed inside the tubular cover to prevent contact between the internal walls of the tubular cover when the negative pressure is applied and to allow the passage of the fluid both in the absence and in the presence of negative pressure ("supports 365 can provide a cushion to prevent the sealed spaces of the bridge 160 from collapsing as a result of external forces" [0104]; FIG. 3A),
Seddon fails to specify the remaining limitations. However, Cotton teaches “wound dressings comprising medical tubes for use in negative pressure wound therapy” (Field of the Invention) wherein the anti-collapse element (“resilient scaffold 30” SPECIFIC DESCRIPTION OF THE INVENTION; FIG. 1) comprises a joining portion (“the point at which the connector tube 36 emerges from the sheath 22”; FIG. 1) having a first extreme inside the tubular cover and a second extreme outside the tubular cover connectable to the negative pressure source (“scaffold 30 extends from the sheath 22 at the distal end of the drainage tube 20 and forms a connector tube 36 for connection to a source of reduced pressure”; FIG. 1), in particular by means of a connection tube (“the medical tube is to be connected to another medical tube, port or medical device” GENERAL DESCRIPTION OF THE INVENTION), wherein said joining portion is fixed to the tubular cover at a contact region, in particular at the first extreme, of said joining portion (“sheath 22 is heat sealed 28 to the surface of the connector tube 36 at the point at which the connector tube 36 emerges from the sheath 22 in order to form a robust fluid-impermeable seal” SPECIFIC DESCRIPTION OF THE INVENTION; FIG. 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Seddon to arrive at the claimed invention as taught by Cotton to “to form a robust fluid-impermeable seal” (SPECIFIC DESCRIPTION OF THE INVENTION).
Regarding Claim 2, Seddon discloses the connector consists solely of the deformable tubular cover and the anti-collapse element ("bridge may comprise: a spacer layer comprising an outer surface, an inner surface, and a plurality of supports extending from the inner surface" [0013]; FIG. 3A).
Regarding Claim 3, Seddon discloses the tubular cover is made in one piece having a circular section when the negative pressure is not applied ([0132]; FIG. 8). NOTE: the limitation that “the tubular cover is made by means of extrusion” is a product-by-process claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.
Regarding Claim 4, Seddon discloses the anti-collapse element is made of a non-absorbent material ("one or more of the first layer 315, the second layer 320, and the spacer layer 375 may comprise or consist essentially of a thermoplastic polyurethane (TPU) film that is permeable to water vapor but impermeable to liquid" [0116]).
Regarding Claim 5, Seddon discloses the anti-collapse element is deformable and comprises a flat semi-rigid structure ("bridge 160 may have a substantially flat profile" [0097]; FIG. 3A) and comprises polymeric material ("spacer layer 375 may be formed from a non-porous, polymeric film that may comprise any flexible material that can be manipulated to form suitable support features, including various thermoplastic materials" [0114]).
Regarding Claim 6, Seddon discloses the flat semi-rigid structure is a fishbone structure comprising a central longitudinal element and two sets of teeth extending orthogonally from two opposite sides of said central longitudinal element (see FIG. 22).
Regarding Claim 7, Seddon discloses the flat semi-rigid structure is a double comb structure comprising a first comb component having a first longitudinal element from which a plurality of first teeth extends and a second comb component having a second longitudinal element from which a plurality of second teeth extends, wherein the first comb component is connected to the second comb component at the ends of the first longitudinal element and the second longitudinal element, and wherein the first comb component is coupled to the second comb element such that a portion of a tooth of the plurality of first teeth is arranged in a space between two consecutive teeth of the plurality of second teeth ([0119]; FIG. 3D).
Regarding Claim 8, Seddon discloses the first comb component is connected to the second comb component by a contact cross member ("third layer 2105 may be in stacked relationship with and sealingly coupled to either the first layer 315 or the second layer 320" [0188]; FIG. 21B), wherein said contact cross member comprises a recess to facilitate the passage of the fluid ("third layer 2105 may be coupled to the second layer 320 about the perimeter, forming an additional fluid pathway (e.g. a third pathway) that may extend from the port to the recessed space (e.g. distal end)" [0188]).
Regarding Claim 9, Seddon discloses the plurality of first teeth lies on a plane offset from the plane on which the plurality of second teeth lies (see FIG. 3D).
Regarding Claim 10, Seddon discloses the joining portion is fixable to the tubular cover by means of electro-welding, chemical welding, radiofrequency welding, and/or gluing ("welding (RF or ultrasonic), heat sealing, or adhesive bonding, such as acrylics or cured adhesives" [0100-0101]).
Regarding Claim 11, Seddon discloses the joining portion of the anti-collapse element is provided with a through hole ("central lumen 305" [0099]; FIG. 3A) which extends along the entire joining portion and wherein, in the passage from the first end to the second end inside the tubular cover when the negative pressure is applied ("third pathway 350 may be fluidly coupled to or configured to be fluidly coupled to the central lumen 305" [0101]; FIG. 3A), the fluid initially flows surrounding the anti-collapse element and then flows inside said anti-collapse element at the joining portion through the through hole ("first pathway 340, the second pathway 345" [0103]).
Regarding Claim 12, Seddon discloses the first end of the tubular cover is closed, in particular by gluing, heat-welding and/or electro-welding ("first layer 315 and the second layer 320 may be coupled around the periphery of the bridge 160 to form the sealed space by welding (RF or ultrasonic), heat sealing, or adhesive bonding" [0100]), and comprises a hole for the passage of fluid inside the connector ("first wall 330 and the second wall 335 may form distinct fluid pathways within the sealed space between the first layer 315 and the second layer 320" [0101]).
Regarding Claim 13, Seddon discloses A medical kit for treating a wound and removing a fluid from said wound by means of the use of a negative pressure system ("Systems for managing fluid at a tissue site is also described herein, wherein some example embodiments may include a negative-pressure source; and a bridge fluidly coupled to the negative-pressure source" [0013]), the kit comprising: the flexible connector according to claim 1 (see above); and a plaster applicable to a wound ("dressing 110" [0062]) and connected to the flexible connector at the first end of the deformable tubular cover of said flexible connector ("bridge 160 may fluidly couple the dressing 110" [0066]; FIG. 2), wherein the flexible connector is connected to the plaster by means of a connection cover ("applicator 240 adapted to be positioned in fluid communication with the tissue interface 120 through an aperture in the cover 125" [0095]) to increase the adhesion between the flexible connector and the plaster and to protect the plaster in the event of traction of the flexible connector ("for facilitating a connection to the dressing 110" [0099]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seddon/Cotton in view of Earl et al. (US 20230201445 A1).
Regarding Claims 14-15, Seddon/Cotton fails to specify the claimed structures of the plaster. However, Earl teaches apparatuses, systems, devices and methods of treating a wound with reduced pressure ([0055]) wherein the plaster ("multi-layer wound dressings" [0057]) consists of a first layer ("backing layer 820" [0103]; FIG. 7C) made of polymeric material ("backing layer 820, which may for example be a polyurethane film" [0116]), a second layer in contact with the first layer and made of silicone adhesive material to attach the plaster to the epidermis of a patient ("lower pressure sensitive adhesive may be provided on the lower surface 824 of the wound dressing 700 … pressure sensitive adhesive, which may be a silicone, hot melt, hydrocolloid or acrylic based adhesive" [0106]), and a third layer arranged between the first layer and the second layer to facilitate the passage of fluid ("transmission layer 826 can be located above the wound contact layer 822" [0107]; FIG. 7C), wherein the second layer comprises a central opening to allow contact of a portion of the third layer with a patient's wound ("perforations 825 preferably comprise through holes in the wound contact layer 822 which enable fluid to flow through the layer 822" [0105]); the third layer is made of non-absorbent material ("layer 826 may be formed of a material having a three-dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used" [0107]) to allow the passage of the fluid when the negative pressure is applied ("transmission layer 726 allows transmission of fluid including liquid and gas away from a wound site into upper layers of the wound dressing" [0107]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Seddon to incorporate the claimed plaster structures as taught by Earl to suitably supply negative pressure through the dressing to the wound ([0059-0060]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
