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 .
Claim Interpretation
The instant specification at paragraph [33] explicitly defines the term “capillary channel” (recited at least at claim 1, line 7) as follows:
“As used herein, including the claims, the phrase "capillary channel" means an elongated void of consistent, increasing, decreasing or fluctuating width in a non-absorbing material surface along which a liquid, for example a liquid disinfectant such as isopropyl alcohol, can flow without the assistance of, or even opposition to, external forces such as gravity by means of capillary action (e.g., the liquid wicks due to fine, narrow capillary channel(s) facilitating molecular surface tension and the ensuing capillary action sufficient to retain and transport (migrate) the liquid along the surface of the body forming the channel).” (emphasis added)
The above definition is limiting on the recitations of the term “capillary channel” in the claims.
Response to Amendment
The amendments filed 25 November, 2025, amended claims 1, 7, 10-13, 15-16, and 21, and cancelled claims 2-6, 8-9, and 19-20. Claims 1, 7, 10-18, and 21 are pending and have been fully considered.
The previously set forth rejections of claims 20-21 are withdrawn in view of the amendments to the claims (see applicant’s response filed 25 November, 2025, at page 5, final 4 lines).
Response to Arguments
Applicant’s arguments with respect to the rejections of the claims under 35 U.S.C. 102 and 103 have been fully considered (see applicant’s response filed 25 November, 2025, at pages 6-12).
With respect to the rejections of claims 1, 15, and 18 under 35 U.S.C. 102(a)(1&2) as being anticipated by Browka et al. (US 2021/0146113 A1), the applicant’s arguments (see applicant’s response filed 25 November, 2025, at page 6, final paragraph) are persuasive because Browka does not teach all elements of claim 1 as amended, especially with respect to the claimed capillary channel being defined within a core disposed within a chamber of an element. Accordingly, the previously set forth rejections of claims 1, 15, and 18 under 35 U.S.C. 102(a)(1&2) as being anticipated by Browka et al. (US 2021/0146113 A1) are withdrawn.
With respect to the rejections of claims 1-4, 15, 17, and 19 under 35 U.S.C. 102(a)(1&2) as being anticipated by Corrigan et al. (US 2020/0269033 A1) (and the associated rejection of dependent claim 16 under 35 U.S.C. 103), the applicant asserts that independent claim 1 has been amended to incorporate subject matter from claim 5, and concludes that amended claim 1 is allowable over Corrigan because Corrigan was not been applied in a rejection of claim 5 (see applicant’s response at page 6, final paragraph). The applicant’s arguments are persuasive in part, because Corrigan does not clearly teach a core formed of a non-absorbent closed-cell foam material. Accordingly, the previously set forth rejections of claims 1-4, 15, 17, and 19 under 35 U.S.C. 102(a) as being anticipated by Corrigan are withdrawn because Corrigan does not teach every element of claim 1 as amended.
However, the examiner does not accept the applicant’s assertion that claim 1 is “allowable” (response at page 6, final two lines) over Corrigan because the applicant has not established that the differences between the device of Corrigan and the device of claim 1 are non-obvious. Instead, the examiner finds that Corrigan is a suitable primary reference for a rejection of claim 1 under 35 U.S.C. 103. Particularly, Figs. 1-2 of Corrigan depict a device (102) including an element (cap 104) which defines a chamber (interior cavity 110) with an open end (opening 106), and a core (cover 120) received inside the chamber (110) ([0037]). The core (cover 120) includes a base (122) including a first face (inner surface 126) facing the open end (opening 106) and a second face (outer surface 128) opposite the first face, the core further including a side face (sidewall 130 with outer surface 134 and inner surface 132) ([0038]). Furthermore, the core includes microfeatures (121) which retain a liquid disinfectant ([0042]) and transport the liquid via capillary action ([0043]) to disinfect a medical fitting (male-taper fitting 152) which interfaces with the device (102) ([0048]), wherein the microfeatures can be configured as channels (through-holes, slots, apertures, or perforations) extending through the base (122), i.e., from the first face to the second face of the core (Fig. 1, [0039]; also Fig. 4, [0055]). Additionally, Corrigan contemplates various materials for the core (120) ([0040]), including foam ([0041]), and recognized the importance of material selection for achieving a desired capillary effect ([0043]-[0045]).
Thus, it is evident that amended claim 1 is only distinguished from Corrigan in that Corrigan does not explicitly teach the core being formed of a non-absorbent closed-cell foam material and the element being formed of a non-absorbent elastic material. The modified grounds of rejection presented below includes a rejection of claim 1 under 35 U.S.C. 103 which demonstrates the obviousness of such material selection when the teachings of Corrigan are combined with Kerr and Cady. Said rejection highlights that Kerr suggests a non-absorbent closed cell foam material for a “core” component, and Cady suggests an elastic material for an “element” component.
With respect to the rejections of claims 1 and 20 under 35 U.S.C. 102(a)(2) as being anticipated by Howlett et al. (US 2022/0134079 A1), the applicant’s arguments are similarly persuasive in part because Howlett does not teach all features of claim 1 with respect to the core being formed of a non-absorbent closed-cell foam material and the element being formed of a non-absorbent elastic material. Accordingly, the previously set forth rejection of claims 1 and 20 under 35 U.S.C. 102 as being anticipated by Howlett are withdrawn.
However, the examiner disagrees with the assertion that claim 1 is “allowable” over Howlett (page 6, final two lines) because embodiments of Howlett can be combined with teachings from other references to demonstrate the obviousness of the device of claim 1. Particularly, Howlett teaches a device (antiseptic medical connector cover 100) including an element (body portion 110) defining a chamber (rigid reservoir 120) with an open leading end (see Fig. 8A) ([0043]). A core (fluid retention structure 121) is disposed inside the chamber and includes capillary channels which retain and transport a disinfectant fluid to a medical connector with which the device interfaces (IPA drawn out of fluid retention structure and onto the face of the target medical connector by capillary action—[0014]; channels extend through cylinder parallel long central axis of cylinder—[0023]). The embodiment of the core (121) depicted in Figs. 10A-B and described at paragraphs [0023] and [0050] most clearly defines a core having a first face, second face, and side face (see Fig. 10B), with capillary channels extending from the first face through the core to the second face (see [0023]), and with the core inserted into the chamber (see [0050]) such that the first face may be defined as the face directed toward the opening of the element (body portion 110). Other embodiments (Figs. 1, 6-7) include cores (retention structures 121) which define channels (voids between fins/vanes) which retain disinfecting fluid and deliver disinfecting fluid to a medical connector ([0014], [0047]), the channels appearing to extend through the entire length of the core (see Figs. 1 and 6-7). Furthermore, Howlett is explicitly clear in suggesting that the device be formed of non-absorbent material to improve safety (see [0004], [0008], [0010]).
Accordingly, the disclosed embodiments of Howlett are only distinguished from the device of amended claim 1 in that Howlett does not particularly teach the core is formed of a non-absorbent, closed-cell foam and the element is formed from a non-absorbent elastic material. The modified grounds of rejection presented below includes a rejection of claim 1 under 35 U.S.C. 103 which demonstrates the obviousness of such material selection when the teachings of Howlett are combined with Kerr and Cay. . Said rejection highlights that Kerr suggests a non-absorbent closed cell foam material for a “core” component, and Cady suggests an elastic material for an “element” component.
With respect to the rejections under 35 U.S.C. 102 and 103 which rely on Kerr et al. (US 2010/0200017 A1) as a primary reference, the applicant traverses the rejections on the basis that” “Kerr does not disclose slits 111 open to opposing end faces of the insert 110 as claimed” (applicant’s response at pages 8-11); and “Kerr does not reasonably disclose that the slits 111 are capillary channels configured to generate a capillary effect to transport the liquid disinfectant along the device 115 as claimed” (applicant’s response at pages 11-12). The applicant’s arguments are persuasive in part because the previously cited embodiments of the core (insert 110) of Kerr does not include slits/capillary channels which extend all the way through (i.e., from a first face to an opposing second face) the core. Accordingly, the rejections over Kerr under 35 U.S.C. 102 and 103 as previously set forth are withdrawn.
However, upon further search and consideration, a modified grounds of rejection of claim 1 and certain dependent under 35 U.S.C. 103 as being unpatentable over Kerr in view of Howlett and Cady is set forth below. The modified grounds of rejection finds that Kerr teaches embodiments (Figs. 25-27) of a core (insert 210) having a cylindrical shape defining at least a first face, second face, and side face (see Fig. 26) and which is retained within a chamber (see Fig. 27) of an element (holder 114) ([0095]-[0096]). The core (210) is formed by rolling a sheet (200; Fig. 25) and cutting slits (211) into the rolled sheet ([0095]). The material of the core is a foam ([0096]), encompassing embodiments wherein the foam is a polymeric closed-cell foam ([0008], [0080]), which is a non-absorbent material based on at least the instant specification at paragraph [38]. Although the slits (211) of Kerr do not extend the entire length from the first face to the second face (Fig. 26), it is evident that the rolled sheet defines slits between the rolled layers which do extend the entire length of the insert. The examiner finds that such slits fairly define capillary channels since the small dimensions of the slits would be expected to transport fluid retained by the insert by cohesive and adhesive forces.
Nonetheless, to the extent to which it is not clear that the identified slit(s) of Kerr necessarily define(s) (a) capillary channel(s), the modified grounds of rejection under 35 U.S.C. 103 presented below finds that it would be obvious to apply the teachings of Howlett to configure the channels for such function. Particularly, Howlett suggests forming a cylinder by rolling a sheet having a textured surface, the textured surface comprising grooves and ridges which yield channels extending along the length of the cylinder when the sheet is rolled (see Howlett at Figs. 10A-B, [0023], and [0050]), the channels configured to deliver disinfectant by capillary action ([0014]). Therefore, modifying the embodiment of the core (210) of Kerr such that the sheet (200) includes a textured surface which forms channels, as suggested by Howlett, yields capillary channels which are clearly consistent with claim 1.
The modified grounds of rejection acknowledges that, Kerr and Howlett do not particularly teach that the element is formed of a non-absorbent elastic material. Nonetheless, the modified grounds of rejection finds that it would be obvious to select a non-absorbent elastic material in view of the teachings of Cady et al. (US 2009/0297400 A1), as previously applied in the rejection of (now cancelled) claim 5, and restated in the modified rejection of claim 1 presented below.
The modified grounds of rejections presented below further includes updated rejections of dependent claims in response to the claim amendments.
The subject matter of Claims 18, as best understood, appears allowable for the reasons indicated below. However, it is requested that the applicant clarify the support for the particular subject matter of claim 18 in the originally filed disclosure of the instant invention in a future response.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Corrigan et al. (US 2020/0269033 A1) in view of Kerr et al. (US 2010/0200017 A1) and Cady et al. (US 2009/0297400 A1).
Regarding claim 1, Corrigan teaches a medical end-site disinfecting device comprising: An interface device (102) for interfacing with a medical end-site (device 102 configured for use with a male luer device 150—Figs. 1-2, [0046]), the interface device including:
An element (cap 104) forming a chamber that is open to a leading end of the element (cap 104 includes opening 106 to interior cavity 110—[0037]);
A core (cover 120) defining a first end face (126), a second end face (128), a side face (cover 120 includes base 122 with inner surface 126 facing cap opening 106 and opposite surface 128—[0038]; viewing Figs. 1-2, the base 122 is essentially a disc shape with a thin side face, the cover 120 also including larger sidewalls 130), and at least one capillary channel (microfeatures 121) that is open to each of the first end face and the second end face (cover 120 includes microfeatures 121 on the inner surface 126 of the base 1222, which can include through-holes, slots, apertures, or perforations that extend all the way through the base 122—[0039]; from Figs. 1-2, such microfeatures 121 clearly define capillary channels open to the first and second end faces 126, 128).
Wherein the core (120) is disposed within the chamber (110) with the first end face (126) facing the leading end (106) (inner surface 126 faces cap opening 106—[0038]),
And further wherein the core (120) is formed of a foam (cover can be made from foams—[0041]); and
A volume of liquid disinfectant retained along the capillary channel (microfeatures 121 of the cover 120 are configured to retain a liquid disinfectant—[0042]);
Wherein the at least one capillary channel is configured to generate a capillary effect to transport the liquid disinfectant along the interface device (micro feature [121] is a feature that can transport liquid via capillary action—[0043]).
See Figs. 1-2 of Corrigan below.
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Additionally, Corrigan recognized that material selection and microchannel dimensions should be accounted for when configuring a microchannel to achieve a desired capillary effect ([0043]-[0045]).
Nonetheless, Corrigan does not explicitly teach the core being formed of a non-absorbent closed-cell foam material and the element being formed of a non-absorbent elastic material.
With respect to the selection of a non-absorbent closed-cel foam, Kerr, in the analogous art of cleaning devices for medical connectors (insert of foam material rotated on exterior medical device to clean exterior surfaces thereof—abstract), suggests forming a core (insert 110) which retains a liquid disinfectant (retain a cleansing substance such as an antibacterial solution…the cleaning substance [suspended] on the surface of the fingers [of the insert]) of a low density, closed cell polyethylene foam ([0080]). The instant specification discloses low density, closed cell polyethylene foam as a type of non-absorbent foam (see paragraph [38]). Therefore, it would be obvious to a person having ordinary skill in the art to select a non-absorbent, closed cell polyethylene foam as the foam material of Corrigan for the benefit of selecting a material which is resistant to tearing, stable in the presence of the cleaning substance, an capable of retaining the cleaning substance by a capillary effect (see Kerr at [0080]; also Corrigan at [0041] suggesting a foam material, and [0042]-[0045] suggesting tailoring material selection for a desired capillary effect).
Corrigan and Kerr do not indicate that the element being formed of a non-absorbent elastic material.
However, in the analogous art of articles for sanitizing medical line connectors, Cady teaches an article comprising a sanitizing element disposed in a shell ([0034]) wherein the sanitizing element comprises a substrate which retains a sanitizing solution. Embodiments of the sanitizing element use capillary action to retain and transfer sanitizing liquids in desired amounts ([0039]). The shell defines a housing for the sanitizing element ([0049]). Accordingly, the shell and sanitizing element of Cady are analogous to the claimed element and core, respectively. Cady further suggests that the shell can be formed of a thermoplastic elastomer, which is an elastic material ([0054]). It is thus evident that thermoplastic elastomers are a non-absorbent, elastic material, which can appropriately serve as a housing for a sanitizing element within a medical connector disinfecting device. A person of ordinary skill in the art would recognize that the rubbery and plastic properties of thermoplastic elastomers (see Cady at [0054]) would allow the housing to flex and return to an original shape without breaking, which can be advantageous when maneuvering the housing over the medical connector to be disinfected.
Therefore, it would be obvious to a person having ordinary skill in the art to further modify the invention Corrigan by selecting a non-absorbent elastic material for the element (cap 104)—such as a thermoplastic elastomer, as suggested by Cady ([0054])—for the evident benefit of achieving a balance of structural flexibility and rigidity suitable for engaging the element with a medical line connector.
Claims 1, 10-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kerr et al. (US 2010/0200017 A1) in view of Howlett et al. (US 2022/0134079 A1) and Cady et al. (US 2009/0297400 A1), or, alternatively, Howlett et al. (US 2022/0134079 A1) in view of Kerr et al. (US 2010/0200017 A1) and Cady et al. (US 2009/0297400 A1).
Regarding claim 1, Kerr teaches a medical end-site disinfecting device (scrub brush 115) comprising:
An interface device for interfacing with a medical end-site (scrub brush 115 interfaces with luer connector—see [0091]-[0092], [0094], Fig. 27), the interface device including:
An element (holder 114) forming a chamber (cavity of holder 114—[0095]) that is open to a leading end of the element (see Fig. 27, holder 114 clearly defines a cavity with an open end);
A core (insert 210) defining a first end face, a second end face, a side face (see Fig. 26: top end, bottom end, and sides of cylindrically shaped insert 210 define first, second, and side faces), and at least one capillary channel that is open to each of the first end face and the second end face (insert 210 formed by rolling a sheet 200 into a cylindrical shape—see [0095], Figs. 25-26; although the cut slits 211 do not extend through the entire cylinder, it is evident that the space between the rolled up layers of the sheet 200 in the insert 210 define slits that extend from the top end to the bottom end of the insert 210),
Wherein the core (210) is disposed within the chamber (of holder 114) with the first end face facing the leading end (see Fig. 27, top face of insert 210 faces open end of holder 114),
And further wherein the core is formed of a non-absorbent closed-cell foam (sheet 200 formed of a suitable material, including polyethylene foam—[0096]; closed foam—[0008]; low density, closed cell polyethylene foam—[0080]; note that the instant specification at paragraph [38] identifies low density closed cell polyethylene foam as a non-absorbent closed cell foam, and thus the low density closed-cell polyethylene foam of Kerr is presumed non-absorbent); and
A volume of liquid disinfectant retained along the capillary channel (suitable cleaning substance added to insert 210—[0095]; cleansing substance is germicide, such as 70% IPA with 2% chlorhexidine gluconate—[0086]; closed cell material including sufficient surface tension to suspend the cleaning substance on the surface of the fingers—[0080]; liquid retained by fingers—[0088]; viewing Figs. 25-27, the space between rolled layers of the sheet 200 define surfaces of fingers 212, and said space is thus understood to retain the cleaning substance);
See Figs. 25-27 of Kerr below:
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The capillary channel (space between layers of rolled sheet 200 in insert 210) of Kerr is understood to assist in the delivery of disinfectant (germicide—[0086]) to a medical device (cleaning substance3carried by fingers disinfects the surfaces of a catheter and removes any biofilm disposed thereon—[0092]). Also, the element (holder 114) is understood to correspond to a housing (21) of a corresponding embodiment (Figs. 1-7), which is made of an alcohol compatible plastic material such as polypropylene or polyethylene ([0046]).
Nonetheless, Kerr is not explicitly clear in teaching that the at least one capillary channel is configured to generate a capillary effect to transport the liquid disinfectant along the interface device, and Kerr further d does not clearly teach the element (holder 114) is formed of a non-absorbent elastic material.
Further regarding claim 1, Howlett teaches a medical end-site disinfecting device (antiseptic medical connector cover 100—[0043]) comprising: An interface device (100) for interfacing with a medical end-site (antispastic connector cover disinfects and protects connectors of needless injection system and IV connectors—[0009]; antiseptic medial connector engages a medical fitting such as NIS, IV, or other Luer type fitting—[0014]), the interface device including:
An element (extended body portion 110) forming a chamber (rigid reservoir 120) that is open to a leading end of the element ([0043]; see Fig. 8A, body 110 includes an open end at connector receiver portion 130);
A core (fluid retention structure 121—[0043]; see embodiment of Figs. 10A-10B, discussed at [0050]) defining a first end face, a second end face, a side face, (see Fig. 10B, embodiment of retention structure 121 is cylindrical and clearly comprises opposing first and second faces and a side face extending therebetween) and at least one capillary channel that is open to each of the first end face and the second end face (sheet of material having a textures surface is rolled into a cylinder and inserted into the reservoir cavity, the texture comprising a series of linear ridges and valleys, or grooves or channels, so that channels remain open between layers and extend through the cylinder parallel with the long central axis of the cylinder—[0023]; also see Figs. 10A-B, [0050]; it is thus evident that the grooves in the sheet of Fig. 10A form microchannels which extend from opposing faces of the cylinder which is formed when the sheet is rolled, as seen in Fig. 10B)
Wherein the core (121) is disposed within the chamber (of housing 110) with the first end face facing the leading end (sheet of material with textured surface is rolled into a cylinder and inserted into the reservoir cavity formed in the body housing—[0023]; it is evident one face of the structure 121 will face the opening of the body 110, which thus defines a first end face),
And further wherein the core (retention structure 121 of Figs. 10A-B) is formed of a non-absorbent material, and the element is formed of a non-absorbent material (device of the present invention eliminates absorbent material—[0008], [0010]); and
A volume of liquid disinfectant retained along the capillary channel (fluid resides in channels—[0010]);
Wherein the at least one capillary channel is configured to generate a capillary effect to transport the liquid disinfectant along the interface device (IPA will be drawn out of the fluid retention structure and onto the face and threads of the target medical connector by the force of surface tension or capillary action—[0014])
See Figs. 10A-10B showing the cited embodiment of the core (retention structure 121) of Howlett, and Fig. 8A showing the element (110) which includes a chamber with an opening for receiving the core.
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Howlett suggests selection of non-absorbent materials in order to improve safety ([0004]-[0005] identifies safety challenges associated with absorbent sponges in medical connector cleaning devices; [0008] establishes that the device of Howlett does not include such an absorbent material).
Nonetheless, Howlett does not clearly teach that the core is a non-absorbent closed cell foam and that the element is a non-absorbent elastic material.
From the above, it would be obvious to a person having ordinary skill in the art to modify the device of Kerr such that the sheet (200) used to form the core (insert 210) is adjusted to include a textured surface so as to define channels extending through the rolled up-cylinder, as suggested by Howlett (see [0023], [0050], Figs. 10A-B), for the benefit of providing capillary channels capable of transporting disinfectant to the medical connector being treated (Howlett indicates that disinfectant fluid resides in the channels—see [0010]—and the fluid is drawn out of the fluid retention structure [i.e., the channels] and onto the face and threads of the target medical connector by the force of surface tension or capillary action—[0014]).
Alternatively, it would be obvious to a person having ordinary skill in the art to modify the device of Howlett by selecting a low density closed cell polyethylene foam as the non-absorbent material of the sheet which forms the core of Howlett (retention structure 121, see Figs. 10A-B of Howlett) for the benefit of providing a material which is suitably resistant to tearing, stable in the presence of the disinfectant, and appropriately deformable (Kerr at [0080] suggests low density closed cell polyethylene foam as a core material, indicating that a suitable material should offer sufficient deformability, resistance to tearing, and stability in the presence of a cleaning substance).
In either instance (i.e., Kerr in view of Howett, or Howlett in view of Kerr), the combination of Kerr and Howlett does not particularly suggest that the element is formed of a non-absorbent elastic material.
However, in the analogous art of articles for sanitizing medical line connectors, Cady teaches an article comprising a sanitizing element disposed in a shell ([0034]) wherein the sanitizing element comprises a substrate which retains a sanitizing solution. Embodiments of the sanitizing element use capillary action to retain and transfer sanitizing liquids in desired amounts ([0039]). The shell defines a housing for the sanitizing element ([0049]). Accordingly, the shell and sanitizing element of Cady are analogous to the claimed element and core, respectively. Cady further suggests that the shell can be formed of thermoplastic elastomers, which are an elastic material ([0054]). It is thus evident that thermoplastic elastomers are a non-absorbent, elastic material, which can appropriately serve as a housing for a sanitizing element within a medical connector disinfecting device. A person of ordinary skill in the art would recognize that the rubbery and plastic properties of thermoplastic elastomers (see Cady at [0054]) would allow the housing to flex and return to an original shape without breaking, which can be advantageous when maneuvering the housing over the medical connector to be disinfected.
Therefore, it would be obvious to a person having ordinary skill in the art to further modify the invention of Kerr (as modified in view of Howlett above), or, alternatively, further modify the invention of Howlett (as modified in view of Kerr above), by selecting a non-absorbent elastic material for the element (holder 114 of Kerr or body 110 of Howlett)—such as a thermoplastic elastomer, as suggested by Cady ([0054])—for the evident benefit of achieving a balance of structural flexibility and rigidity suitable for engaging the element with a medical line connector.
Regarding claim 10, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. Howlett teaches the core defines a plurality of capillary channels (plurality of grooves or channels formed on the surface of the film…film is cut perpendicular to the plurality of channels and rolled into a cylinder so the channels remain open between layers and extend through he cylinder parallel with the central axis of the cylinder—[0023]; also see Figs. 10A-B, [0050]).
Regarding claim 11, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. Howlett further teaches the capillary channel is defined as a groove or channel (series of linear ridges and valleys, or a plurality of grooves or channels formed in the film—[0023]; see Figs. 10A-B).
Regarding claim 12, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. As discussed in the version of the rejection of claim 1 above wherein Kerr is used as a primary reference, the gap between the rolled layers of the sheet (200) of the insert (210) of Kerr defines at least one channel extending from a first end face to an opposing end face of a core (insert 210), and it would be obvious to modify the sheet of Kerr in to include a textured surface in view of the teachings of Howlett discussed above for the benefit of defining capillary channels configured to deliver disinfectant within the gaps between the layers of the rolled sheet of Kerr (see rejection of claim 1 above). Viewing Fig. 26 of Kerr, the gap between the layers spirals out and ends at a side face of core (210); thus, modified Kerr fairly teaches at least one capillary channel is open relative to the side face. Alternatively, the similarly rolled layers of the core of Howlett would reasonably include at least one channel or gap open to the side face at the outer end of the spiral formed by the gap between layers (see [0023], [0050]).
Regarding claim 13, the combination of Kerr in view of Howlett and Cady teaches the disinfecting device of claim 12. Kerr further teaches the core has a cylindrical shape (see Fig. 26 of Kerr, insert 210 clearly has a cylindrical shape); alternatively, Howlett also teaches a cylindrical core (see Fig. 10B, [0023], [0050]).
Regarding claim 14, , the combination of Kerr in view of Howlett and Cady teaches the disinfecting device of claim 13. Howlett teaches the core defines a plurality of capillary channels, and further wherein each of the plurality of capillary channels are open to at least the first end face and the second end face (see [0023], [0050], Figs. 10A-B; the grooves of the sheet seen in Fig. 10A form a plurality of microchannels when the sheet is formed into a cylinder as seen in Fig. 10B, the channels extending from opposing first and second ends—see [0023], [0050]). Alternatively, Kerr, as modified with respect to claim 1 above, is modified to incorporate the above feature of Howlett (i.e., Kerr is modified so that sheet 200 includes a textured surface of grooves and ridges to form microchannels when rolled into cylindrical insert 210); thus modified Kerr similarly teaches a plurality of capillary channels open to the first and second end faces.
Regarding claim 15, the combination(s) of Kerr and Howlett in view of Cady teaches the
disinfecting device of claim 1. Howlett suggests that the element (body portion 110 defining a reservoir) and core (retention structure 121 within reservoir) can be provided within a sterile package (reservoir filled with IPA, sealed with a cap or film, and then placed into a sterile package—[0026],[0028]). Such a sterile package fairly defines a housing having a cavity in which the element and core are disposed; thus, Howlett teaches the interface device includes the element disposed within a cavity of a housing. Alternatively, it would similarly be obvious to provide the device of modified Kerr in a sterile package, as suggested by Howlett, for the benefit of providing the interface device in a housing which protects the device from contamination before use.
Regarding claim 16, the combination(s) of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 15. Howlett indicates that the housing is a sterile package ([0026], [0028]). Howlett recognized that absorbent materials present in medical connector cleaning devices can pose safety risks, such as by absorbing bodily fluids ([0004]). Also, a person of ordinary skill in the art would recognize that plastic materials are conventional materials for use as a packaging material. Therefore, it would be obvious to a person having ordinary skill int eh art to further modify the device of Howlett (as modified with respect to claim 15), or, alternatively, Kerr (as modified with respect to claim 15), such that the housing (sterile packaging) is formed of a non-absorbent plastic material for the benefit of selecting a material which will not retain unwanted fluids and which is suitable for packaging the interface device.
Regarding claim 21, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. Kerr teaches a lid removably secured to the interface device (removably lid—[0004], [0010]-[0011], [0051], Figs. 1-2; holder includes a cap to cover an opening to the cavity defined by the holder—claim 10). Alternatively, Howlett further teaches a lid removably secured to the interface device (concave protective cap 200…with pull tab 220 for removal of cap 200 from threaded opening 130 of connector cover 100—Fig. 9, [0049]).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination(s) of Kerr et al. (US 2010/0200017 A1) and Howlett et al. (US 2022/0134079 A1) in view of Cady et al. (US 2009/0297400 A1), as applied to claim 1 above, and further in view of Solomon et al. (US 8,172,825 B2, cited in IDS filed 10 November, 2022).
Regarding claim 7, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. Kerr, Howlett, and Cady do not teach that the element defines at least one capillary channel (wherein an element is defined by claim 1 as being a non-absorbent elastic material which forms a chamber with an open end which receives the core).
However, in the analogous art of disinfecting medical connectors (title), Solomon teaches a device (cap 2304) wherein a housing (2350) defines a sterilization chamber (2358) and a coupling interface (2342) to facilitate disinfection of a male Luer (2020) or similar medical connection (Figs. 40-45, column 33, lines 10-31). A sealing member (2390) is positioned within the housing above a resiliently compressible pad (2370); a male luer inserted into the device housing presses down on the sealing member (2390) and pad (2370), releasing antiseptic fluid (2333) to the outer surfaces of the male Luer through channels (2393) that extend through the sealing member (2390) (column 33, line 62, through column 34, line 19). The housing further includes channels (venting channels or vents 2353) in the sidewall (2352) of the housing (column 34, lines 56-67), which allow antiseptic to exit the chamber (column 35, lines 1-26). The housing (2350) with sidewalls (2352) having channels (2353) correspond to the claimed element defining at least one capillary channel, and the sealing member (2390) with channels (2393) of Solomon correspond to a the claimed core comprising at least one capillary channel.
Therefore, it would be obvious to a person having ordinary skill in the art to further modify the device of Kerr (as modified with respect to claim 1 above), or, alternatively, further modify the device of Howlett (as modified with respect to claim 1 above), such that the element (holder 114 or Kerr; body portion 110 of Howlett) defines at least one channel, as seen in Solomon, for the benefit of providing a release path for antiseptic solution when an inserted Luer device seals with the sidewalls of the element (see Solomon at column 35, lines 1-10). Such channels reasonably define capillary channels as cohesive and adhesive forces would assist the flow of the antiseptic through the channel.
Regarding claim 17, the combination(s) of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 15. Kerr, Howlett, and Cady do not clearly teach that the element defines at least one capillary channel. However, for the reasons discussed with respect to claim 7 above, it would be obvious to a person having ordinary skill in the art to further modify Kerr or Howlett in view of Solomon such that the element defines at least one microchannel for the benefit of providing a release path for antiseptic solution when an inserted Luer device seals with the sidewalls of the element (see Solomon at column 35, lines 1-10).
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 18, the combination(s) of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 15. Kerr, Howlett, and Cady do not teach that the housing defines at least one capillary channel. Claim 18, which depends from claim 15 and claim 1, is understood to essentially require a nested structure with an outermost component defined by the claimed housing, an intermediate component defined by the claimed element, and an innermost component defined by the claimed core, wherein both the core and the housing include capillary channels. The housing defines a cavity which receives the element, and the element defines a chamber which receives the core.
Anderson et al. (US 2019/0070404 A1, previously cited) teaches a capping and cleaning device for needle free vascular access connectors (title, abstract), which includes a three component nested structure (capping and cleansing device 10) roughly corresponding to a housing component (cap portion 11), an element component (resilient inner body 30), and a core component (compressible cleansing matrix 80) (Fig. 2A, [0084]-[0087]), but Anderson does not teach capillary channels as claimed arranged in both the core component and the housing component. Also, Anderson does not fairly suggest modifying Kerr or Howlett to incorporate the three-component nested structure, wherein both the core and the housing include capillary channels.
No prior art was found which teaches the particular arrangement of claimed elements, especially wherein both a core and a housing include capillary channels and wherein an element is effectively positioned between the element and housing. Accordingly, the subject matter of claim 18 appears novel and non-obvious over the prior art.
However, it is noted that the embodiment of claim 18 is weakly supported by the written disclosure and drawings. For example, although Fig. 21i teaches an interface assembly including a housing and core which both have capillary channels, the “element” is omitted in the disclosed embodiment (paragraph [73]). Other disclosed embodiments include all three of the core, element, and housing (Figs. 21A-C and G), but the embodiments of Figs. 21A-K do not set forth the particular combination of the core, element, and housing, with capillary channels in both the core and housing. There does not appear to be a disclosed embodiment which corresponds to the particularly claimed combination, although the claimed embodiment may fall within “the spirit and scope of the present disclosure” (instant specification at paragraph [74]). Accordingly, the examiner requests that the applicant clarify which embodiments from the written disclosure support the invention of claim 18 and/or how claim 18 falls within the scope of written disclosure.
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.
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797