DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/02/2026 has been entered.
Information Disclosure Statements
The information disclosure statement(s) filed with the most recent response are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
Claims 17, 18, 20, 23-25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (U.S. Pat. 10,238,856, hereinafter “Tennican”) in view of Gawande et al (U.S. Pub. 2011/0311647 A1, hereinafter “Gawande”), further in view of Gardner (U.S. Pat. 10,046,156 B2, hereinafter “Gardner”), further in view of further in view of Perdew, Jr. et al (U.S. Pat. 6,727,210 B1, hereinafter “Perdew”).
Regarding claim 17, Tennican discloses a luer connection cleaning cap kit comprising:
a luer cap (one of 806a, 806b and 806c shown in Fig. 8A; the cap is understood to have cap design corresponding to cap 100 shown in Fig. 1A) comprising:
a luer cap body affixable to a luer port (see col. 2, lines 18-20, disclosing a female luer cap designed to be threaded onto a luer port), the cap body including an interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity);
a seal enclosing a first composition within the interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity), wherein the seal is configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal (see, e.g., protective cover 102 in Fig. 1A which hermetically seals the cap; the seal being "configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal" does not impart a structural limitation to the seal itself other than being able to be punctured, which the seal in Tennican is capable of, thereby permitting the composition to be applied to the luer port);
a wipe packet (see soap package/pouch 804 which can be used to wipe the site initially; see col. 6, lines 39-42) including a second composition (the soap package can include “any known cleanser used in the medical industry”; see col. 6, lines 39-42), wherein the first composition comprises EDTA at a concentration of:
at least about 1% (w/v) (see col. 6, lines 48-57 disclosing the antimicrobial solution includes a chelating agent; and see col. 7, lines 10-17, disclosing a solution containing EDTA in the incorporated U.S. app. 12/874,188, which itself discloses EDTA in the range of 50-150 mg/ml, equated to 5-15% w/v; see the published U.S. app no. 2011/0052664 A1 at para [0045]);
ethanol at a concentration from about 10% (w/v) to about 30% (w/v) (see para [0045], disclosing ethanol at a concentration from about 5% to approximately 30%);
It is noted that Tennican does not appear to disclose that the first composition further comprises chlorhexidine in a concentration from about 0.1 µg/mL to about 100 µg/mL).
Gawande discloses an antimicrobial composition for applying to an injection site or another surface susceptible to colonization by biofilm embedded microorganisms, (see para [0087]), comprising chlorhexidine in the concentration of 0.1 µg /mL to about 100 µg/mL (see para [0011]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican so that the second composition comprises chlorhexidine, which is a known antibacterial/antiseptic agent for the skin having advantageous germicidal power, in the concentration of 0.1 µg /mL to about 100 µg/mL, as taught in Gawande, in order to prevent or reduce infection by preventing growth of biofilm embedded microorganisms, with a reasonable expectation of success.
Further, it is noted that Tennican does not appear to disclose that the first composition has a pH of at least 9.5.
Gardner discloses that its EDTA antimicrobial solution formulation can have a pH above a physiological pH, such as at least 9.5 (see col. 22, line 67 to col. 23, line 8).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican so that its antimicrobial solution has a pH of at least 9.5, as taught in Gardner, in order to inhibit the growth and reproduction of many common microorganisms, with a reasonable expectation of success.
It is noted that Tennican does not appear to disclose that the material in the packet includes a towelette and the second composition is an antimicrobial composition comprising EDTA at a concentration of at least about 1% w/v (as noted above, Tennican discloses that the material in the packet can contain “any known cleanser used in the medical industry” but does not specifically disclose the composition of the cleanser). Further, as to claim 18, Tennican also does not disclose that the towelette comprises an absorbent material to absorb the second composition.
Perdew discloses a towelette 14 (see Fig. 3-4) stored in a pouch 12 (see Fig. 3 and col. 5, line 47) that is used to clean a treatment site of a patient (such as the epidermis; see Abstract and see col. 1, lines 57-60), the towelette comprising an absorbable material (paper; see col. 5, line 45) containing an absorbed antimicrobial solution containing EDTA at a concentration of at least about 1% w/v (see col. 4, lines 21-23 disclosing EDTA in the amount up to 10%).
A skilled artisan would have found it obvious at the time of the invention to modify the wipe packet of Tennican so that it includes a towelette with a second antimicrobial composition, as such a towelette was taught in Perdew to be used to “clean oneself to prevent infections as well as to minimize the spread of diseases” (see Perdew at col. 1, lines 12-15), and making the modification to Tennican would have been reasonably expected to permit the Tennican device to function effectively to clean a surgical site such as the skin.
Regarding claims 20 and 23, it is noted that Tennican does not appear to disclose that the first composition further comprises heparin, taurolidine, a thrombolytic agent or a combination thereof; and specifically, regarding claim 23, Tennican does not appear to disclose the heparin being in the concentration of 1% (w/v) to about 8% (w/v).
Gardner discloses that its antimicrobial cap includes an anti-microbial solution as well as heparin (see col. 9, lines 35-43). Further, Gardner discloses that desirable antimicrobial solutions may include an anticoagulant in the concentration of 1%-99% by volume.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican to incorporate heparin with its first antimicrobial solution, which is a known antithrombogenic agent (see Gardner at col. 20, line 64), in order to prevent or reduce thrombosis with a reasonable expectation of success, thereby improving the compatibility of the device with which the cap is designed to be used. A skilled artisan would have found it obvious to modify the concentration to be from 1% to about 8% (w/v), based on the teaching in Gardner that the concentration of a coagulant can range from 1% to 99%. It would have been within the level of ordinary creativity of one having skill in the art to vary the concentration of the coagulant for a desired effect, barring criticality or unexpected results.
Regarding claim 24, Tennican does not appear to disclose that the first composition comprises a thrombolytic agent, and the thrombolytic agent comprises alteplase, streptokinase, reteplase, tenecteplase, urokinase, prourokinase, anistreplase, or a combination thereof.
Gardner discloses that its antimicrobial cap includes an anti-microbial solution as well as urokinase or streptokinase (see col. 15, lines 63-65 and col. 19, lines 25-30).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican to incorporate a thrombolytic agent such as urokinase or streptokinase with its first antimicrobial solution, in order to prevent or reduce thrombosis with a reasonable expectation of success, thereby improving the compatibility of the device with which the cap is designed to be used.
Regarding claim 25, it is noted that Tennican does not appear to disclose that first composition comprises taurolidine, and the taurolidine has a concentration in the first composition from about 1 % (w/v) to about 8% (w/v).
Gardner discloses that its antimicrobial cap includes an anti-microbial solution with taurolidine (see col. 15, lines 24-27), which may be present in solution from 1 to 99% by volume (see col. 15, lines 18-23).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican to incorporate taurolidine with its first antimicrobial solution, which is a known antimicrobial agent (see Gardner at col. 15, lines 25-27), in order to prevent or reduce infection with a reasonable expectation of success. Further, a skilled artisan would have found it obvious to modify the concentration to be from 1% to about 8% (w/v), based on the teaching in Gardner that the concentration of a coagulant can range from 1% to 99%. It would have been within the level of ordinary creativity of one having skill in the art to vary the concentration of the anticoagulant for a desired effect, barring criticality or unexpected results.
Regarding claim 27, it is noted that Tennican, in view of Gardner, further in view of Perdew, does not appear to disclose that the second composition further comprises chlorhexidine or a pharmaceutically acceptable salt thereof; and as per claim 28, the chlorhexidine or a pharmaceutically acceptable salt thereof has a concentration in the second composition from about 0.1 µg /mL to about 100 µg/mL.
Gawande discloses an antimicrobial composition for applying to an injection site or another surface susceptible to colonization by biofilm embedded microorganisms, (see para [0087]), comprising chlorhexidine in the concentration of 0.1 µg /mL to about 100 µg/mL (see para [0011]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican so that the second composition comprises chlorhexidine, which is a known antibacterial/antiseptic agent for the skin having advantageous germicidal power, in the concentration of 0.1 µg /mL to about 100 µg/mL, as taught in Gawande, in order to prevent or reduce infection by preventing growth of biofilm embedded microorganisms, with a reasonable expectation of success.
Regarding claim 29, that Tennican, in view of Gardner, further in view of Perdew does not appear to disclose that the second composition further comprises ethanol.
Gawande discloses an antimicrobial composition for applying to an injection site or another surface susceptible to colonization by biofilm embedded microorganisms, (see para [0087]), comprising ethanol (see para [0067]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican so that the second composition comprises ethanol, which is a known disinfection agent for the skin (see Gawande at para [0069]), in order to prevent or reduce infection with a reasonable expectation of success.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican in view of Gawande, further in view of Gardner, further in view of further in view of Perdew, further in view of Koenig et al (U.S. Pub. 2002/0183216 A1, hereinafter “Koenig”).
Regarding claim 26, it is noted that Tennican, in view of Gardner, further in view of Perdew, does not appear to disclose that the second composition further comprises heparin, taurolidine, a thrombolytic agent, or a combination thereof.
Koenig discloses an antimicrobial composition for skin cleansing (see Abstract), comprising heparin (see para [0035]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Tennican, in view of Gardner, further in view of Perdew, to incorporate heparin with its second antimicrobial solution, as taught in Koenig, in order to prevent or reduce infection with a reasonable expectation of success.
Claims 30-32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican, in view of Perdew.
Regarding claims 30 and 35, Tennican discloses a luer connection cleaning cap kit comprising:
a luer cap (one of 806a, 806b and 806c shown in Fig. 8A; the cap is understood to have cap design corresponding to cap 100 shown in Fig. 1A) comprising:
a luer cap body affixable to a luer port (see col. 2, lines 18-20, disclosing a female luer cap designed to be threaded onto a luer port), the luer cap body including an interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity);
a seal enclosing a first composition within the interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity), wherein the seal is configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal (see, e.g., protective cover 102 in Fig. 1A which hermetically seals the cap; the seal being "configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal" does not impart a structural limitation to the seal itself other than being able to be punctured, which the seal in Tennican is capable of, thereby permitting the composition to be applied to the luer port);
a wipe packet (see soap package/pouch 804 which can be used to wipe the site initially; see col. 6, lines 39-42) including a second composition (the soap package can include “any known cleanser used in the medical industry”; see col. 6, lines 39-42).
It is noted that Tennican does not appear to disclose that the material in the packet includes a towelette.
Perdew discloses a towelette 14 (see Fig. 3-4) stored in a pouch 12 (see Fig. 3 and col. 5, line 47) that is used to clean a treatment site of a patient (such as the epidermis; see Abstract and see col. 1, lines 57-60), the towelette comprising an absorbable material (paper; see col. 5, line 45); as per claim 35, Perdew also discloses that the towelette comprises a second composition containing an absorbed antimicrobial solution containing EDTA at a concentration of at least about 1% w/v (see col. 4, lines 21-23 disclosing EDTA in the amount up to 10%).
A skilled artisan would have found it obvious at the time of the invention to modify the wipe packet of Tennican so that it includes a towelette with a second antimicrobial composition comprising EDTA at a concentration of at least about 1% (w/v) (as per claim 35), as such a towelette was taught in Perdew to be used to “clean oneself to prevent infections as well as to minimize the spread of diseases” (see Perdew at col. 1, lines 12-15); making the modification to Tennican would have been reasonably expected improve the effectiveness of the device when cleaning a surgical site such as the skin.
Regarding claims 31 and 32, Tennican discloses that the first composition comprises EDTA at a concentration of:
at least about 1% (w/v) (see col. 6, lines 48-57 disclosing the antimicrobial solution includes a chelating agent; and see col. 7, lines 10-17, disclosing a solution containing EDTA in the incorporated U.S. app. 12/874,188, which itself discloses EDTA in the range of 50-150 mg/ml, equated to 5-15% w/v; see the published U.S. app no. 2011/0052664 A1 at para [0045]);
ethanol at a concentration from about 10% (w/v) to about 30% (w/v) (see para [0045], disclosing ethanol at a concentration from about 5% to approximately 30%).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican, in view of Perdew, further in view of Gawande.
Regarding claim 33, It is noted that Tennican, in view of Perdew, does not appear to disclose that the first composition further comprises chlorhexidine in a concentration from about 0.1 µg/mL to about 100 µg/mL).
Gawande discloses an antimicrobial composition for applying to an injection site or another surface susceptible to colonization by biofilm embedded microorganisms, (see para [0087]), comprising chlorhexidine in the concentration of 0.1 µg /mL to about 100 µg/mL (see para [0011]).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Tennican, in view of Perdew, so that the second composition comprises chlorhexidine, which is a known antibacterial/antiseptic agent for the skin having advantageous germicidal power, in the concentration of 0.1 µg /mL to about 100 µg/mL, as taught in Gawande, in order to prevent or reduce infection by preventing growth of biofilm embedded microorganisms, with a reasonable expectation of success.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican, in view of Perdew, further in view of Gardner.
Regarding claim 34, it is noted that Tennican, in view of Perdew, does not appear to disclose that the first composition has a pH of at least 9.5.
Gardner discloses an antimicrobial solution of EDTA having a physiological pH such as at least 9.5 (see col. 22, line 67 to col. 23, line 8).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Tennican, in view of Perdew, so that its antimicrobial solution has a pH of at least 9.5, as taught in Gardner, in order to inhibit the growth and reproduction of many common microorganisms, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered.
Applicant argued that Tennican does not teach or suggest the seal "as contemplated in amended claim 17" (see Remarks, pg. 6; Examiner notes that even though claim 30 was not specifically addressed in the arguments, claim 30 also recites the same seal limitation).
Examiner refers Applicant to the rejection herein, which explains that Tennican discloses a luer cap (one of 806a, 806b and 806c shown in Fig. 8A; the cap is understood to have cap design corresponding to cap 100 shown in Fig. 1A) comprising:
a luer cap body affixable to a luer port (see col. 2, lines 18-20, disclosing a female luer cap designed to be threaded onto a luer port), the luer cap body including an interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity);
and a seal enclosing a first composition within the interior cavity (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution in an interior cavity), wherein the seal is configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal (see, e.g., protective cover 102 in Fig. 1A which hermetically seals the cap; the seal being "configured to release the first composition into a luer access device (LAD) comprising a luer port when the luer cap body is secured to the luer port of the LAD and the LAD punctures the seal" does not impart a structural limitation to the seal itself other than being able to be punctured, which the seal in Tennican is capable of, thereby permitting the composition to be applied to the luer port).
The remaining arguments amount to attacking references individually even though the rejections were based on the combination of references. When an obviousness rejection relies on a combination, nonobviousness cannot be established solely by attacking the references individually. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/23/2026
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