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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 May, 2026 has been entered.
Response to Amendment
The amendments filed 27 May, 2026, have been entered. Claims 1 and 7 are amended. Claims 2-6, 8-9 and 18-20 are cancelled. Claims 22-25 are new. Claims 1, 7, 10-17, and 21-25 are pending and have been fully considered.
Response to Arguments
Applicant’s arguments with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered (see applicant’s response filed 27 May, 2026, at pages 6-14).
With respect to the rejection of claim 1 over the combination of Corrigan et al. (US 2020/0269033 A1), Kerr et al. (US 2010/0200017 A1), and Cady et al. (US 2009/0297400 A1), the applicant argues that the cited microfeatures of Corrigan do not fairly define capillary channels consistent with the claim, especially with respect to the claim requiring that the capillary channel be configured to generate a capillary effect to transport the liquid disinfectant along the interface device without assistance of external forces (response at pages 6-9, especially paragraph 2 of page 8).
In response, the examiner first emphasizes that, as per MPEP 2114(II.), a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Accordingly, the patentability of claim 1 over the prior art cannot be established on functional language alone absent a demonstration that the functional language yields structural difference in the claimed invention with respect to the prior art. In the instant case, the applicant has asserted that the operation of the device of Corrigan involves localized retention and contact transfer at micro features, or externally driven flow through structural openings, and thus concludes that the device of Corrigan does not teach a capillary channel configured to transport a liquid disinfectant without the assistance of external forces. However, the applicant’s arguments do not establish how the difference in operation between the device of Corrigan and the claimed device would necessarily yield a structural distinction. Also, Corrigan explicitly indicates that the micro features are capable of transporting liquid via capillary action ([0043]). While the described use of the device of Corrigan may differ from the intended use of the claimed device, there is insufficient evidence to suggest that the cited microfeatures of Corrigan are incapable of transporting liquid without the assistance of external forces, as such function is essentially the definition of transportation by capillary action. Accordingly, the applicant’s arguments are not persuasive and the examiner holds that the capillary channel of Corrigan is at least capable of transporting a disinfectant liquid without the assistance of external forces.
With respect to the rejections of claim 1 over the combinations of Kerr et al. (US 2010/0200017 A1), Howlett et al. (US 2022/0134079 A1), and Cady et al. (US 2009/0297400 A1), the applicant similarly argues that Kerr, and alternatively Howlett do not teach capillary channels consistent with the claims, especially with respect to the capillary channels being configured to transport liquid disinfectant without the assistance of external forces (response at pages 10-12). The applicant also asserts the proposed modifications lack a reasoned basis (page 11 ,paragraph 2).
In response to the arguments pertaining to the claimed capillary channel, the examiner disagrees on a similar grounds as discussed above with respect to Corrigan. Although the devices of Kerr and Howlett may be described as being used in a manner somewhat different from the claim, the applicant has not demonstrated that the devices of [modified] Kerr and Howlett possess a structural difference that would inhibit their capillary channels from transporting liquid without the assistance of external forces, i.e., achieve capillary transport. Instead, Howlett discloses channels which deliver a liquid by the force of surface tension or capillary action ([0014]), which supports the finding that the device of Howlett and modified device of Kerr are capable of capillary transport. Accordingly, the applicant’s argument is not persuasive.
In response to the applicant’s arguments with respect to the lack of a reasoned basis, the examiner disagrees as the previously set forth rejection proposed modifications which included the following rationales:
- modifying 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 seen in Howlett (see [0023], [0050], Figs. 10A-B), for the benefit of providing capillary channels capable of transporting disinfectant to the medical connector being treated (see Howlett at [0010] and [0014]);
-modifying the device of Howlett in view of Kerr by selecting a low density closed cell polyethylene foam as the non-absorbent core material for the benefit of providing a material which is suitably resistant to tearing, stable in the presence of the disinfectant, and appropriately deformable (see Kerr at [0080]); and
-modifying the device of Howlett or Kerr by selecting a non-absorbent elastic material for the element, such as a thermoplastic elastomer as seen in Cady ([0054]), for the benefit of achieving a balance of structural flexibility and rigidity suitable for engaging the element with a medical line connector.
Accordingly, the examiner finds that the proposed modifications included a reasoned basis. The applicant’s argument further implies that the examiner's conclusion of obviousness is based upon improper hindsight reasoning. In response, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the applicant’s argument with respect to a lack of a reasoned basis is not persuasive.
In view of the above, the previously set forth rejections of claim 1 under 35 U.S.C. 103 are maintained, with language added to address the amendment to claim 1. The rejections of dependent claims 10-16 and 21 are similarly maintained.
With respect to amended claim 7, the applicant sets forth an argument with respect to the vent (2353) of Solomon not functioning as a capillary channel which transports a liquid absent an external force (response at pages 12-13). In this instance, the applicant’s argument is persuasive because Solomon does not provide sufficient evidence to suggest that the vent can act as a capillary channel as claimed. Accordingly, the previously set forth rejection of claim 7 is withdrawn. The reconsideration of claim 7 further prompted the reconsideration of similar claim 17, and after further search and consideration, the subject matter of claims 7 and 17 has been found allowable as set forth below.
With respect to new Claims 22-25, the claims have been assessed for obviousness over the prior art, as set forth in the new rejections under 35 U.S.C. 103 and indications of allowable subject matter below.
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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It is emphasized that Corrigan teaches the capillary channel can transport liquid via capillary action ([0043]), which fairly implies the capillary channel is capable transporting the liquid disinfectant without the assistance of external forces (also see the response toa arguments above).
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, and 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, 21, and 23 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 substance carried 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 without the assistance of external forces, and Kerr further 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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It is emphasized that Howlett teaches that disinfectant is drawn out of the fluid retention structure by capillary action ([0014]), which reasonably indicates that the capillary channels of Howlett are at least capable of transporting a fluid without the assistance of an external force (also see response to arguments above).
Furthermore, 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]).
Regarding claim 23, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. Howlett teaches the capillary channels having a rectangular cross sectional shape (see Figs. 10A-B). Thus, Howlett, Kerr, and Cay do not fairly suggest the at least one capillary channel defines a cross shape in extension between the first end face and the second end face. However, changes in shape are prima facie obvious absent evidence of significance; see MPEP 2144.04(IV.)(B.). Accordingly, changing the cross-sectional shape of the capillary channel of modified Howlett from rectangular to cross shape is presumed obvious in view of the absent of evidence of significance; also, such modification may be reasonably expected to advantageously increase a volume of liquid the capillary channel can transport by increasing cross sectional area while maintain a high surface tension throughout the channel. This finding of obviousness may be rebutted by persuasive arguments and evidence establishing the significance of the claimed shape.
Allowable Subject Matter
Claims 7, 17, 22, and 24-25 are 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 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 configured to transport the liquid disinfectant along the element without the assistance of external forces (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).
Solomon et al. (US 8,172,825 B2), in the analogous art of disinfecting medical connectors (title), 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) roughly 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.
However, the channels of the housing of Solomon (venting channels 2353) are not clearly disclosed as achieving capillary transport, or otherwise being sufficiently narrow and of an appropriate material to be capable of achieving capillary transport of a liquid. Accordingly, Solomon is not sufficient to suggest further modification of Kerr or Howlett to include at least one capillary channel configured to transport the liquid disinfectant along the element without the assistance of external forces.
No further prior art was found which reasonably teaches or suggests a device comprising all limitations of claim 7, especially with respect to the combination of a non-absorbent core material having capillary channels extending therethrough being positioned within a chamber of an element formed of a non-absorbent elastic material, the element comprising a further capillary channel [within the element]. Accordingly, the subject matter of claim 7 is found novel and non-obvious over the prior art.
Regarding claim 17, it is first emphasized that the instant specification defines the phrase “capillary channel” at paragraph [33] of the specification as meaning “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)”. Since this definition is interpreted as applying to claim 17, claim 17 closely overlaps in scope with claim 7 and thus is allowable for substantially the same reasons as discussed above.
Regarding claim 22, the combination of Kerr and Howlett in view of Cady teaches the disinfecting device of claim 1. As discussed with respect to claim 12 above, the modified device of Kerr presented with respect to claim 1 above comprises a gap between layers of the core (210) which spirals out and ends at a side face of the core (Kerr at Fig. 26), wherein such gap may fairly define a capillary channel that is open relative to the side face, as well as the first and second end faces. Also, as modified with respect to claim 1, the core of Kerr includes additional channels formed by cutting slits into the core before it is rolled into a cylinder, said channels being open to the first end face and second end face. Nonetheless, the gap is substantially connected to all of the channels of the modified device, and the formed channels are not open to the side face of the core. Accordingly, modified Kerr does not teach the at least one capillary channel includes a first capillary channel that is open to each of the first end face, the second end face, and the side face, and a second capillary channel not connected to the first capillary channel that is open to each of the first end face, the second end face, and the side face.
None of the cited art clearly suggests adopting such an arrangement of capillary channels in addition to all limitations of claim 1, and no further prior art was found which teaches all limitations of claim 22. Accordingly, the subject matter of claim 22 is found to be novel and non-obvious over the prior art.
Regarding claim 24, the disinfecting device of claim 1 is taught by a combination of either: 1) Corrigan, Kerr, and Cady; 2) Kerr, Howlett, and Cady; or 3) Howlett, Kerr, and Cady (see rejections under 35 U.S.C. 103 above). Claim 24 further requires that the core is a homogenous, solid body that self-defines and maintains a columnar, cylindrical shape apart from the element. This claim language is understood to require that the core have a non-hollow (apart from the capillary channels) cylindrical shape which will not easily deform or degrade if the core is removed from the element.
Accordingly, this claim language distinguishes the claimed core from the cited cores of Kerr and Howlett, which are formed by rolling a sheet structure into cylinder and stuffing the cylinder into a chamber of an element, because the cited cores of Kerr and Howlett would not be expected necessarily maintain a cylindrical shape if removed from the element (the rolled cores would reasonably be expected to readily unravel).
The claim language further distinguishes the claimed core from the cited core of Corrigan, as the disclosed cores of Corrigan form a hollow, open ended cylindrical structure when positioned in the chamber of the cited element, and most embodiments of the core of Corrigan are depicted as having a fanned disc-like shape when outside of the element (see Figs. 1-2, 5-9; Figs. 10-11 show a system 1002 with a basket shaped embodiment, but the hollow shape of the basket is understood as being distinct form a homogenous solid body as claimed).
Cady also fails to address these deficiencies of the cited art.
No further prior art was found which teaches or reasonably suggests a device which combines all limitations of claim 1 with the further requirement that the core be a homogenous, solid body that self-defines and maintains a columnar, cylindrical shape apart from the element. Accordingly, the subject matter of claim 24 is considered novel and non-obvious over the prior art.
Claim 25 contains allowable subject matter by virtue of dependency on claim 24.
Conclusion
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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