DETAILED 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.
Claim(s) 1-8 and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchman (US 2008/0132880) in view of Found (US 2011/0028563).
Regarding claims 1, 4 and 5, Buchman discloses a disinfecting device comprising a container configured to engage with a medical connector (intended use, device is capable of such), the container containing a chlorhexidine- based solution comprising a chlorhexidine concentration of from 0.2-2.0% wt/vol (¶61, fig 1), an isopropyl concentration of at least 50% wt/vol (¶61).
While Buchman substantially discloses the invention as claimed, it does not disclose a plant-derived oil, wherein the plant-derived oil aids in disengagement of the disinfecting device and the connector by decreasing a removal force to disengage the disinfecting device from the connector.
Found discloses an anti-microbial concentration that also uses chlorohexidine gluconate in some embodiments (¶62). Found also discloses eucalyptus oil as it assists antimicrobial activity of agents (¶10) and is a stabilizer (¶12).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Buchman such that it also discloses a plant-derived oil (especially eucalyptus oil) as taught by Found to assist antimicrobial activity of the agents and is a stabilizer.
It follows from the combination that eucalyptus oil also aids in disengagement of the disinfecting device and the connector by decreasing a removal force to disengage the disinfecting device from the connector (oil acts as a lubricant by decreasing the friction between two structures).
Regarding claim 2, wherein the chlorhexidine concentration is from 0.5-1.0% wt/vol (¶61).
Regarding claim 3, wherein the chlorhexidine-based solution comprises chlorhexidine gluconate (¶61).
Regarding claim 5, wherein the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 25% wt/vol or at least 50% wt/vol (¶61).
Regarding claim 6, wherein the disinfecting device comprises a disinfecting cap or a disinfecting scrubbing device (¶36).
Regarding claim 7, wherein the isopropyl alcohol concentration is at least 70% wt/vol (¶61) and the disinfecting device is configured to engage with a medical connector (¶36 – needleless port).
Regarding claim 8, wherein the medical connector comprises a needle-free connector, a male connector, and/or a stop cock (¶36).
Regarding claim 11, Buchman discloses a disinfected medical connector comprising: a medical connector disinfected with the disinfecting device of claim 1 (¶36 – needleless port screwed into cap).
Regarding claim 12, wherein the disinfecting device comprises a disinfecting cap engaged with the medical connector.
Regarding claim 13, wherein the disinfecting device comprises a scrubbing device 30/40 containing the chlorhexidine-based solution into which the medical connector is submerged (¶36).
Regarding claims 14, 16 and 17, Buchman discloses a method of disinfecting a medical connector comprising submerging the medical connector (¶45, medical connector is inserted through top of fig 2 and submerged in open cell foam 140 and reservoir 170 which has antimicrobial solution) with a chlorhexidine-based solution comprising a chlorhexidine concentration of from 0.2-2.0% wt/vol, an isopropyl alcohol concentration of at least 50%wt/vol contained in a container of a disinfecting device (¶36, ¶61).
While Buchman substantially discloses the invention as claimed, it does not disclose a plant-derived oil, nor wherein the plant-derived oil aids in disengagement of the disinfecting device and the connector by decreasing a removal force to disengage the disinfecting device from the connector.
Found discloses an anti-microbial concentration that also uses chlorohexidine gluconate in some embodiments (¶62). Found also discloses eucalyptus oil as it assists antimicrobial activity of agents (¶10) and is a stabilizer (¶12).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Buchman such that it also discloses a plant-derived oil (especially eucalyptus oil) as taught by Found to assist antimicrobial activity of the agents and is a stabilizer.
It follows from the combination that eucalyptus oil also aids in disengagement of the disinfecting device and the connector by decreasing a removal force to disengage the disinfecting device from the connector (oil acts as a lubricant by decreasing the friction between two structures).
Regarding claim 15, wherein the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 70% wt/vol and the chlorhexidine concentration is from 0.5-1.0 wt/vol (¶61).
Claim(s) 9, 10 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchman (US 2008/0132880) in view of Found (US 2011/0028563) and Kucuk (US 2019/0344017).
Regarding claims 9, 10 and 18-20, while Buchman substantially discloses the invention as claimed, it does not disclose the disinfecting device is additionally sterilized to kill microbes for which the chlorhexidine-based solution is less effective prior to contacting the medical connector with the disinfecting device; wherein the device has been sterilized using steam sterilization, an autoclave, and/or radiation sterilization; wherein the radiation sterilization comprises gamma radiation or E-beam radiation; nor wherein the radiation is in a dose range of from 15-60 kGy.
Kucuk discloses a cap which uses gamma rays with an energy dose of 25-40 kGy to free the device of as far as possible of the microorganisms contained in or adhering to it (¶73).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Buchman such that the disinfecting device is additionally sterilized to kill microbes for which the chlorhexidine-based solution is less effective prior to contacting the medical connector with the disinfecting device; wherein the device has been sterilized using steam sterilization, an autoclave, and/or radiation sterilization; wherein the radiation sterilization comprises gamma radiation or E-beam radiation; and wherein the radiation is in a dose range of from 15-60 kGy as taught by Kucuk to free the device of as far as possible of the microorganisms contained in or adhering to it.
Response to Arguments
Applicant’s arguments are not persuasive.
On pages 5 and 6, Applicant argues the examiner misapplies the legal guidance of In re Kerkhoven, more specifically that the composition in Buchman is vastly different from that in Found. The examiner is not persuaded as both are used for antimicrobial activity (¶10 of Found and ¶61 of Buchman) and thus it would be obvious to combine them to form a mixture suitable for antimicrobial activity.
Applicant argues on page 6 Buchman is drawn to a disinfecting medical connector, while Found pertains to cleaning hard surfaces, hand washing and instrument treatment. The examiner is not persuaded as disinfecting a medical connector can be more generally considered as an instrument treatment.
Applicant also argues on page 6 that there is insufficient evidence that the compositions are known equivalents, nor that the essential oils listed in Found would be useful in Buchman’s different composition. The examiner has pointed out that essential oils in Found have particular advantages to its compositions (such as those found in ¶10) and the examiner has also pointed out that Found lists the antibiotic (chlorohexidine gluconate) disclosed by Buchman (¶62). Thus the examiner has established a reasonable expectation of success with combining the two references.
Applicant repeats on pages 6 and 7 that Found does not pertain to disinfecting a cap that engages a connector and more generally pertains to antimicrobial compositions generally. The examiner is not again not persuaded because one of ordinary skill in the art would recognize that Found discloses instrument treatment, to which Buchman is also drawn.
Applicant argue the examiner’s reliance on Found merely because Found lists chlorhexidine in a list of over 35 different additional ingredients is insufficient to establish a basis to combine the teaching of Found with Buchman, especially as Buchman has already provided an effective disinfection solution for catheter hubs. The examiner disagrees. Chlorhexidine in Found was listed as providing nexus between the references. Found specifically discloses eucalyptus oil as it assists antimicrobial activity of agents (¶10) and is a stabilizer (¶12). Thus Found provides a reason to eucalyptus oil to Buchman and Found listing chlorhexidine in its long list further enhances ones’ already reasonable expectation of success.
Applicant argues on page 8 that Kucuk does not pertain to a disinfecting device comprising a container to engage with a medical connector as claimed, but instead pertains to containers for pharmaceutical preparations and a closure piece that seals a container such as a syringe; and that one would not combine with Buchman as Buchman already contains a solution to reduce microbial contamination. The examiner is not persuaded as Buchman only contains the antimicrobial in specific locations (to disinfect an inserted connector), while Kucuk discloses sterilizing the entire device of Buchman, including surfaces the antimicrobial solution does not contact. The surfaces which the antimicrobial of Buchman does not contact (such as the exterior of the housing; or the interior of the flow channel downstream of the antimicrobial solution when the antimicrobial solution is no longer at a sufficient concentration to kill a sufficient amount of microbes) may contain microbes which a user may contact when making a connection between Buchman and a connector and then transfer said microbes elsewhere, which Kucuk aims to reduce by removing as many microbes contained in and adhering to the device of Buchman.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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