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/Arguments
The Amendment filed 7/21/2025 has been entered. Claims 1-12 and 39 remain pending on the application. Claim 12 is withdrawn pursuant to Applicant’s election filed 8/18/2022.
Applicant argues:
Applicant respectfully disagrees. Throughout the entire disclosure of Ferlic, the foam/foam members are solely described as absorbent materials. At no point in Ferlic is it taught or even suggested that any of the foam members are or could be non-absorbent materials.
According to Applicant's claim 1, a disinfection device is provided that includes (1) a base scrub made of a closed cell foam and (2) a side scrub element made of an open cell foam.
As noted in Applicant's disclosure, in "one or more embodiments the base scrub 130 is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyethylene foam. The foam may be open celled, semi-opened or closed celled" (Para [0038]). As further set out by Applicant, "In one or more embodiments, base scrub 130 is made of an absorbent material. In one or more alternate embodiment, the base scrub is made of a closed cell foam." (Para [0046]) Applicant notes that closed-cell foams are generally understood to be formed of individually sealed cells which are relatively impermeable to liquids. On the other hand, open- cell foams are generally understood to be formed of interconnected air pockets that are permeable to liquids and allow liquids to be easily absorbed. Further, while closed cell foams might be more firm than open cell foams, firmness of foam materials depends on a variety of factors. For example, the firmness of open cell (absorbent) foams can be varied such that, for example, an open cell foam having smaller pore/cell size will generally be firmer than an open cell foam having larger pore/cell size.
Thus, while Ferlic notes that some foam base members can be firmer and less compliant than individual foam members, Ferlic fails to teach or suggest that individual foam members are formed of an open cell foam (absorbent foam) while a base member is formed of a closed cell foam (generally non-absorbent foam). Rather, Ferlic describes that the foam/foam members are absorbent throughout.
Examiner respectfully disagrees. Ferlic does predominantly teach an absorbent material for its foam members. However, Ferlic also teaches the possibility of other materials being used (par. 64: The sterilizing element 20 can be made from a variety of materials including, but not limited to, non-woven, particulate-free absorbent foams, natural or synthetic sponges; par. 150: In some embodiments, the base member 1102e is materially different from the individual foam members). At the very least, Ferlic teaches that the base material can have materially different properties than the other foam members. It is also noted that Ferlic describes base member 1102e as being closed-ended, and Solomon uses the similar terminology to mean a closed-cell foam (par. 297: In certain embodiments, the resilient support 3077 comprises a closed configuration (e.g., closed cell foam).
The Office further points to Solomon (Office Action, p. 8) as allegedly describing a "closed cell foam as a material that is of a closed configuration to serve as material that does not reabsorb the disinfectant (par. 297: In certain embodiments, the resilient support 3077 comprises a closed configuration (e.g., closed cell foam) or is otherwise nonabsorbent such that little or no antiseptic 3033 that is expelled from the pad 3070 is received into the resilient support 3077)."
The Office concludes that it would be obvious to modify the base scrub of Ferlic modified by Kerr to be made of a closed foam material, as taught by Solomon.
Applicant respectfully disagrees. According to Solomon, a "resilient support 3077, which may also be referred to as a post or a base element, can be configured to provide a base against which the antiseptic reservoir or pad 3070 can be compressed so as to force antiseptic 3033 therefrom." (Para [0296]) In some embodiments, this resilient support 3077 can even comprise a compression coil spring (para [0297]). This resilient support 3077 (highlighted in green) is shown and described in connection with FIGS. 66B and 66D below, when a medical device 2000 having a male protrusion (male luer 2020, highlighted in pink) is inserted into the disinfection cap 3004 for disinfection. The male luer contacts the sealing member 3090 (highlighted in blue) and to form a seal (FIG. 66B), then compresses the pad 3070 to forcing antiseptic 3033 out of the pad 3070 and through a fluid path toward the male luer 2020 to bathe the male luer 2020 in antiseptic and disinfect it (FIG. 66D).
As clearly illustrated in FIGS. 66B and 66D above, at no point during connection (FIG.
66B) through the "fully coupled stage" (FIG. 66D) does the resilient support 3077 (highlighted in blue) come into contact with the male luer (highlighted in pink).
Applicant respectfully submits that the resilient support 3077 of Solomon is not at all comparable to Applicant's base scrub. As set out in Applicant's claim 1, the interior wall surface of the annular wall of the side scrub and the base scrub directly contact a distal face and an annular sidewall and threads of a female Luer connector or a male Luer connector.
As such, Applicant further disagrees with the Office's assertion that it would be obvious to modify the base scrub of Ferlic modified by Kerr to be made of a closed foam material (where the resilient support 3077 comprises a closed cell foam) according to Solomon since the portion of Solomon that is formed of a closed cell foam is a completely different part of the device with a completely different function than the claimed base scrub.
Examiner notes that the resilient support 3077 of Solomon is still analogous to the base member 1102e of Ferlic because both are positioned at the bottom relative to the other foam members and are designed to be a stronger/more resilient material compared to the other foams; the resilient support 3077 does not need to be directly analogous to the base scrub of the instant invention in order to be applicable to the primary reference.
Applicant respectfully disagrees. As clearly shown in FIG. 26 and as previously noted, the slit 211 extends from a top surface of the foam "a predetermined distance to define a plurality of fingers 212" (col. 10, lines 42-44) and thus do not extend from the bottom surface to the top surface in accordance with Applicant's claims.
There would be a bottom surface between where the fingers stem from, as illustrated in further embodiments involving the fingers:
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Applicant respectfully disagrees. As illustrated in Ruhof Dry Sponges, the "single slit" does not extend "radially outward from the interior wall surface to the exterior wall surface" as asserted and in accordance with Applicant's claims. Rather, as clearly shown below, Ruhof's sponge includes a center lumen extending through the length of the sponge, and a separate V- shaped cut that extends inward from the exterior wall surface of the sponge. However, this V- shaped cut does not extend to the interior wall surface (i.e., it does not connect with the center lumen). Ruhof provides such a structure so that (a) a tubular instrument can be placed within the V-shaped portion and the sponge compressed about the tubular instrument while the sponge is run up and down the length of the tubular instrument to disinfect it (See "Scope Cleaning"), and (b) the distal end of the scope or medical/surgical instrument can be inserted into the separate lumen portion to protect the tip (See "Tip Protection").
Examiner respectfully disagrees. As previously cited in the rejection to claim 1, the slit does in fact extend to the inner wall surface because the sponge is meant to open up to envelope a tube, as reproduced below:
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This image is found on the bottom of page 1 of the “Ruhof Dry Sponges” PDF.
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 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.
Claims 1-9, 11, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ferlic (US 20130171030 A1) in view of Kerr (US 9192449 B2, provided in Applicant’s IDS of 11/17/2020), Solomon (US 20120039764 A1), Shaw (US 8777504 B2), and “Ruhof Dry Sponges” (NPL 2016).
Regarding claim 1, Ferlic teaches a disinfection device comprising: a container comprising an integral body, an open end, a closed end, an annular wall defining a chamber extending from the closed end to an open end (Fig. 25: housing 1002);
a base scrub disposed in the chamber (Fig. 34: solid foam member 1102e);
a side scrub element having a wall, an exterior wall surface, an interior wall surface, an inner cavity having a center portion, a bottom surface, a top surface (Fig. 34: foam member 1102d),
the side scrub element is disposed onto the base scrub element (Fig. 34),
the interior wall surface of the annular wall of the side scrub and the base scrub directly contact a distal face and an annular sidewall and threads of a female Luer connector or a male Luer connector (Fig. 34)
a disinfectant or antimicrobial agent (par. 126: In some embodiments, the sterilizing element 1004 is impregnated with a liquid antipathogenic agent that evaporates when attached to the end-site. In some embodiments the sterilizing element 1004 is impregnated with a liquid antipathogenic agent and is left on the end-site until sterilizing element 1004 is dry.);
and a removable seal on the open end of the container (par. 133: The upper housing section 1018, including the flange or lip 1024 and the tapered wall section 1028, are sized and shaped to conformingly receive the cap 1006, forming a hermetic seal that maintains the sterilizing element 1004 in a moist state)
but does not teach
wherein the side scrub has an annular wall, wherein annular is interpreted to mean “ring-like”. Instead Ferlic teaches a star-shaped wall (par. 150: As can be further seen in FIGS. 33 and 34, each foam member 1102a, 1102b, 1102c, 1102d includes a corresponding star-shaped opening 1108a, 1108b, 1108c, 1108d).
However, in the absence of any teaching to the contrary, the shape of the side scrub does not affect operation since they would still be capable of receiving and disinfecting a medical connector of a different shape so long as the material is still impregnated with a liquid disinfectant and the material contacts the medical connector. Absent a showing of significance or unexpected results, the shape of the side scrub is prima facie obviousness and does not modify the operation of the invention and further, do not add patentable significance. MPEP2144.04.IV.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). Accordingly, the claimed dimensions and shapes are considered to be not patentably distinct from the disclosed device of Ferlic.
Ferlic itself teaches adapting the shape of the scrub to the shape of a connector (par. 96: Additionally, the sterilizing element 520 is contoured and shaped so that it "form-fits" over the working end-site of a luer compatible connector, device, and/or needle access port for efficient wiping and sterilizing).
Furthermore, Kerr teaches a disinfection scrub for disinfecting a medical connector (Fig. 39, abstract: The microbial scrub brush in one embodiment employs an insert that is impregnated with an anti-bacterial disinfectant and that is housed within a housing of alcohol-compatible material and sealed over by a removable lid).
Kerr teaches wherein the portion surrounding the medical disinfector can take many shapes, one of which is an annular shape (C1L51-54: In one embodiment, the insert is provided with an annular portion for enveloping an outer surface of the female luer as well as a central portion for insertion within a central passage of the female luer for sterilizing an interior of the female luer; Fig. 2, Fig. 7, Fig. 26, Fig. 39A), in order to adapt to medical connectors of different sizes and shapes (C8L58-63: It is appreciated that the holder and the cavity it defines can assume other shapes, including square, round, etc. Indeed, the holder, its cavity, and the insert disposed therein can be configured in shape and size so as to enable the scrub brush 115, as a scrubbing device, to cleanse a particular size and configuration of a medical device).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interior wall of the side scrub 1102d to be annular, as taught by Kerr, with a reasonable expectation that the side scrub would then be adapted for receiving and disinfecting a cylindrically shaped medical connector.
Ferlic modified Kerr still does not teach
the base scrub is made of a closed cell foam.
Ferlic teaches wherein the base scrub is substantially solid and close-ended (par. 149: A substantially solid foam member 1102e is closed-ended) and wherein the base scrub is materially different from the side scrub (par. 150: In some embodiments the base member 1102e is firmer and less compliant than the individual foam members). Therefore, there is already motivation to make the base scrub a closed cell foam, because a closed cell foam is more solid than an open cell foam and is more “close-ended”.
Solomon teaches a medical connector disinfectant scrub (abstract: Caps can be used to cover and disinfect a male protrusion portion of a medical connector. Some caps can create a seal with the male protrusion to prevent antiseptic from entering a lumen the protrusion. A biasing element can aid in creating or maintaining the seal; Fig. 10).
Solomon teaches a closed cell foam as a material that is of a closed configuration to serve as material that does not reabsorb the disinfectant (par. 297: In certain embodiments, the resilient support 3077 comprises a closed configuration (e.g., closed cell foam) or is otherwise nonabsorbent such that little or no antiseptic 3033 that is expelled from the pad 3070 is received into the resilient support 3077).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base scrub of Ferlic modified by Kerr to be made of a closed foam material, as taught by Solomon, in order to have a substantially solid and close-ended material suitable for cleaning and scrubbing medical devices, that does not reabsorb the disinfectant and therefore redirects the disinfectant towards the medical device.
Ferlic modified by Kerr and Solomon does not teach wherein the side scrub element is made of an open cell foam.
Ferlic already provides motivation to have the side scrub elements be made of some absorbent material in order to contain the liquid disinfectant (par. 124: The sterilizing element 1004 can be made from a variety of materials including, but not limited to, non-woven, particulate-free absorbent foams, natural or synthetic sponges, or other suitable materials both semi-flexible or semi-rigid and having malleable, resilient and rebounding properties. In some embodiments, the sterilizing element 1004 includes an absorbent foam article 1014… In some embodiments, the material of the sterilizing element 1004 has capillarity (capillary action), which may also be referred to as a wicking capability, and the properties to disperse a liquid anti-pathogenic evenly throughout and to maintain an even distribution regardless of the sterilizing device's 1000 orientation when stored either upside down, right side-up or on its side).
Shaw teaches a medical connector disinfectant device (abstract: A tool that is useful for cleaning and disinfecting the attachment surfaces of a fluid connector device used in medical applications, the tool having a housing with an opening of defined shape and a chemically treated flexible insert positionable inside the housing that substantially conforms to the inside wall of the housing and, when placed over the attachment surfaces of a fluid connector device, can be manipulated axially and rotationally relative to the attachment surfaces to contact, clean and disinfect the surfaces. Some embodiments can also be used for topical cleaning of skin or other surfaces; Fig. 10).
Shaw teaches wherein an open celled foam is used for a material capable of absorbing a liquid disinfectant (C7L63-C8L3: Sponge 30 is desirably made of a compressible, open-cell material adapted to receive, retain and release a composition containing a disinfectant when sponge 30 is placed in contact with or compressed against an attachment surface of a frontal attachment device such as a CLAVE.RTM. connector. Most preferably, sponge 30 will comprise open-cell polyurethane foam or another similarly effective non-latex, open-cell material).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the side scrub 1102d of Ferlic to be made of an open celled foam, as taught by Shaw, in order to allow the side scrub to absorb a liquid disinfectant that can then be contacted with the medical connector.
Ferlic modified by Kerr, Solomon, and Shaw does not teach
and the side scrub having a single slit that extends vertically from the bottom surface to the top surface and radially outward from the interior wall surface to the exterior wall surface, a center portion of the side scrub may be depressed entirely without separating or detaching from the interior wall surface wherein the slit is part of the scrub element as opposed to the base scrub.
Kerr teaches a slit that extends vertically from the bottom surface to the top surface and radially outward from the interior wall surface to the exterior wall surface, located on the scrub element (Fig. 26: slit 211) in order to allow the scrub member to compress around an insert and thereby enhance sterilization (C10L16-29: Referring to FIG. 24, wherein like reference characters indicate like parts as above, when the catheter 117 is inserted into the foamed insert 110, the fingers 112 that pass into a lumen 118 of the catheter 117 are slightly compressed due in part to the frictional forces between the interior luminal wall of the lumen 118 and the fingers 112 in contact therewith. The degree of compression is such as to enhance the degree of contact between the fingers 112 and the luminal wall of the lumen 118 and thus enhance the scrubbing action of the fingers 112 on the luminal wall. It is appreciated that the same scrubbing enhancement is realized on fingers in contact with exterior portions of the catheter 117 and other suitable portions of medical devices cleansed by the scrub brush, including a female-type luer connector, for instance).
Furthermore, “Ruhof Dry Sponges” teaches a sponge for sterilizing scopes and other tubular medical instruments (pg. 2: Ruhof’s super absorbent Dry Sponges are designed to remove gross contaminants from the outside sheath of all scopes and tubular instruments during the pre-cleaning and manual cleaning process). The dry sponges can be used to envelope the distal end of a medical instrument (pg. 2: Ruhof Dry Sponges can also be used to fit securely around the distal tip of a scope to protect delicate lenses and fiber-optics from damage during transportation. In addition, Ruhof Dry Sponges protect the distal tip of Tee Probes along with other delicate components of various medical/surgical instruments). The dry sponge has a single slit that extends vertically from the bottom surface to the top surface and radially outward from the interior wall surface to the exterior wall surface:
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…in order to compress around medical instruments of various sizes (pg. 2: Super absorbent contoured sponge for all flexible and rigid scopes; see images wherein the dry sponge is wrapped around various different instruments). Thus, having this single slit also accomplishes the function taught by Kerr of compressing a scrub/sponge around a tubular medical instrument in order to enhance sterilization.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scrub element of Ferlic modified by Kerr, Solomon, and Shaw to have at least one slit that extends vertically from the bottom surface to the top surface and radially outward from the interior wall surface to the exterior wall surface, as taught by Kerr and “Ruhof Dry Sponges”, in order to allow the scrub element to compress around an insert and thereby enhance the scrubbing action.
Ferlic modified by Kerr, Solomon, Shaw and “Ruhof Dry Sponges” thus teaches a center portion of the side scrub may be depressed entirely without separating or detaching from the interior wall surface, since the side scrub is made of foam and now has the single slit.
Regarding claim 2, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, and teaches wherein the container comprises a polypropylene or polyethylene material (par. 135: In one embodiment, for example, the housing 1002 can be made from polypropylene (PP)).
Regarding claim 3, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, and teaches wherein the side scrub element is a foam (par. 149: cylindrically-shaped foam members 1102a, 1102b, 1102c, 1102d).
Regarding claim 4, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, but does not teach wherein the side scrub element is a polyurethane foam.
Ferlic itself already suggests a polyurethane foam for the material surrounding the sides of the connector (par. 76: In one embodiment, the absorbent resilient article 47 is fabricated from a viscoelastic foam (e.g., viscoelastic polyurethane foam)) and as previously stated, there is motivation for the foam member 1102d to be an absorbent material (par. 124: The sterilizing element 1004 can be made from a variety of materials including, but not limited to, non-woven, particulate-free absorbent foams, natural or synthetic sponges, or other suitable materials both semi-flexible or semi-rigid and having malleable, resilient and rebounding properties. In some embodiments, the sterilizing element 1004 includes an absorbent foam article 1014… In some embodiments, the material of the sterilizing element 1004 has capillarity (capillary action), which may also be referred to as a wicking capability, and the properties to disperse a liquid anti-pathogenic evenly throughout and to maintain an even distribution regardless of the sterilizing device's 1000 orientation when stored either upside down, right side-up or on its side).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scrub element of Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” to be composed of a polyurethane foam, as taught by Ferlic, as a known material for fulfilling the known need of having an absorbent scrub element for sterilizing a medical connector.
Regarding claim 5, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, and teaches wherein the side scrub element is a sponge (in light of Applicant’s amendment to claim 1 wherein the side scrub element is an open cell foam, then in order for this dependent claim limitation to not contradict claim 1, an open cell foam is interpreted to be a sponge, in which case the Shaw modification in claim 1 makes the side scrub element an open cell foam, which reads on this claim 5 limitation of being a sponge).
Regarding claim 6, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, and teaches wherein a compression of the scrub element toward the closed end of the chamber occurs upon connection to a female Luer connector or a male Luer connector (Fig. 34; NOTE: the structure of the scrub member and the scrub member being a foam would allow it to perform this function if a connector is pressed into it).
Regarding claim 7, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 6, as set forth above, and teaches wherein compression of the scrub element disinfects the female Luer connector or the male Luer connector (par. 21: thus staggering the contact surfaces to create a detail contour opening that contacts and disinfects the working end-site; par. 63: Additionally, the sterilizing element 20 is configured to apply an inclusive layer of an antipathogenic agent to the inner and outer surfaces of the working end-site. An inclusive layer, as used herein, is a layer of the antipathogenic agent applied via the contoured aspects of the sterilizing element which contacts all accessible inner and outer surfaces of the working end-site and contains an amount of the pathogenic agent sufficient to effectively sterilize the working end-site of the medical device. The contoured sterilizing element 20 is intended for a one time, single use, disposable application).
Regarding claim 8, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, and teaches wherein the disinfectant or antimicrobial agent is selected from a group consisting essentially of isopropyl alcohol (par. 66: Exemplary antipathogenic agents include, but are not limited to, the following: isopropyl alcohol, povidone iodine, chlorhexidine gluconate), ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof.
Regarding claim 9, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 6, as set forth above, and teaches wherein the disinfectant or antimicrobial agent is a fluid (par. 126: the sterilizing element 1004 is impregnated with a liquid antipathogenic agent) or a gel.
Regarding claim 11, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, but does not teach wherein the removable seal is heat-sealed or induction sealed to the open end of the container. Ferlic already teaches a peel-away lid but does not teach a technique for attaching the lid to the housing (par. 86: According to one embodiment, the removable cover 162 is a peel-away lid).
Kerr teaches wherein a peel-away lid is attached to the housing via heat sealing (C4L66-C5L7: Referring to FIG. 5, the housing 21 has an annular boss 30 at one end concentric to the cavity 26 for heat sealing of the lid 23 thereon. In this respect, the lid 23 is a die-cut foil lid that is coated with a material that readily heat seals to the polypropylene housing 21 via the boss 30. As indicated in FIG. 1, the lid 23 is provided with a pull tab 31 that extends therefrom and from the housing 21 in order to facilitate manual removal of the lid 23 from the housing 21).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peel-away lid of Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” to be heat sealed to the open end of the container, as taught by Kerr, in order to fulfill the known need of a method of attaching the lid to the container.
Regarding claim 39, Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” teaches the disinfection device of claim 1, as set forth above, but does not teach wherein the base sponge has a planar top surface.
Ferlic teaches wherein some embodiments of the base foam member have a nub but is silent with respect to other possible shapes (par. 150: In some embodiments, and as further shown in FIG. 34, the base foam member 1102e includes an upwardly extending nub 1112 configured to clean a lumen, septum, or other internal or terminal feature or features of the working end-site of the device). However, as cited here, Ferlic teaches that the shape of the base foam member is adapted for cleaning different devices. Therefore, a planar surface might be advantageous for cleaning certain devices.
In the absence of any teaching to the contrary, the shape of the top surface of the base does not affect operation so long as it is adapted to clean a particular instrument. Absent a showing of significance or unexpected results, the shape of the top surface of the base foam member is prima facie obviousness and does not modify the operation of the invention and further, does not add patentable significance. MPEP 2144.04.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant).
Ferlic itself teaches a planar surface for the bottom portion of its scrub (Fig. 4).
Furthermore, Shaw teaches an embodiment wherein the bottom surface of the scrub contacting the sterilization target is planar (Fig. 17).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the top surface of the base foam member of Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” to be planar, as taught by Shaw, with a reasonable expectation that it would adapted to cleaning devices of different shapes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ferlic modified by Kerr, Solomon, Shaw, and “Ruhof Dry Sponges” (hereinafter referred to as Modified Ferlic), in further view of Charles (US 20130085474 A1, provided in Applicant’s IDS of 9/9/2020).
Regarding claim 10, Modified Ferlic teaches the disinfection device of claim 1, as set forth above, and teaches wherein the removable seal is a peel back top (par. 86: According to one embodiment, the removable cover 162 is a peel-away lid) but does not teach wherein the removable seal comprises an aluminum or multi-layer polymer film peel back top.
Charles teaches a medical device disinfection scrubber (Fig. 2, par. 12: In one or more embodiments, the disinfection is provided by a reservoir collar that contains a disinfectant housed within a compartment in the reservoir collar). Charles teaches a peel-able seal for the disinfection scrubber made of aluminum or a multi-layer polymer film (claim 12: wherein the seal comprises an aluminum or multi-layer polymer film peel back top).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal of Modified Ferlic to be composed of aluminum or multi-layer polymer film, as taught by Charles, in order to provide suitable materials for forming a peel-back seal for use in a medical connector disinfection scrubber.
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 CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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, Elizabeth A. Robinson can be reached on (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796