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 .
Response to Amendment
Examiner acknowledges the reply filed 03/18/2026. Claim 17 was amended. Claims 19, 21 and 22 were canceled. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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 connection cleaning cap kit comprising:
a cap (one of 806a, 806b and 806c; see Fig. 8A) including a first composition (see col. 6, lines 48-57 disclosing that the cap includes an antimicrobial solution); and
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 cap is a luer cap.
Gardner discloses an antiseptic cap including a first antimicrobial composition (see col. 6, lines 48-51), the antiseptic cap being a luer cap (see Figs. 32-36 showing the cap with the antimicrobial solution in an absorbent pad 86, as disclosed in col. 6, lines 43-55, and showing luer threads in the cap). Gardner also discloses, in background, that luer fittings are the medical industry’s standard fitting for connections of catheters to various other devices such as catheter caps used to seal the end of a catheter and protect the sterility of the catheter and prevent contamination (see col. 1, lines 59-65).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the cap of Tennican to be a luer cap, which was known as the industry-standard connector for a cap to a catheter, and in doing so would have found a reasonable expectation of success in connecting to, and subsequently cleaning, a medical port.
Further, 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).
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 22, Tennican discloses that the first composition further comprises ethanol (see col. 7, lines 10-25).
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.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered.
Applicant argued (Remarks, pg. 7):
"The person skilled in the art would have no motivation to modify Tennican based on the disclosure of Gardner because nothing in either Tennican or Gardner teaches or suggests specifically combining EDTA, ethanol, and chlorhexidine. Gardner teaches a variety of antiseptic compositions, but not one of the antiseptic composition described in Gardner combines EDTA and chlorhexidine. The mere fact that references can be combined or modified does not render the resultant combination obvious unless the results would have been predictable to one of ordinary skill in the art. MPEP § 2143.01(111)."
The Examiner notes that Applicant’s argument against Tennican in view of Gardner is largely moot, given the amendments to the claims specifying the concentration of chlorhexidine in the first composition. The Gawande reference was incorporated into the rejection to teach this feature.
Even so, Applicant’s argument primarily addresses Tennican and Gardner individually, whereas the rejection is 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).
Moreover, Applicant argued that "nothing in Gardner or any of the remaining cited art would specifically motivate the skilled artisan to combine EDTA with chlorhexidine and ethanol." (Remarks, pg. 8). This argument relies on a strict teaching, suggestion or motivation test for obviousness. However, such strict evidence is not an absolute requirement for an obviousness rejection in light of the teachings of KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). See MPEP 2143.
Applicant also argued that the claimed combination of EDTA, ethanol and chlorhexidine showed "significantly improved ability to eradicate biofilms of several bacterial and fungal species" (see Remarks, pg. 8), citing the composition's' "synergistic effect" (Id.).
While MPEP § 716.02(a) recognizes that synergism (defined as an effect greater than the sum of individual effects) may support nonobviousness, a greater-than-additive effect alone does not necessarily overcome a prima facie case of obviousness. The effect must be unexpected relative to prior art and provide a significant practical advantage. See Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991).
In this case, Applicant has not shown that the claimed invention's synergistic effect was unexpected. The claims encompass a much broader range of EDTA, ethanol, and chlorhexidine concentrations than supported by the experimental data in the specification. For example, the claimed composition has no maximum EDTA concentration whatsoever, and moreover, permits a chlorhexidine concentration within three orders of magnitude (i.e., a factor of 1000 between the lowest concentration and the highest concentration).
For at least these reasons, Applicant's arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 03/31/2026
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