DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/30/2026 has been entered.
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 Objections
Claim 1 is objected to because of the following informalities: in line 4, Applicant has two commas separated by a space “, ,”. Appropriate correction is required.
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 contacting the medical connector 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 argues the rejection is based on impermissible speculation and unfounded assumptions as Buchman already provides an effective disinfection solution for catheter hubs.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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). In the instant application, the reconstruction is based upon the knowledge gleaned from two references which were available to one of ordinary skill in the art.
Further, it is now well settled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F2d 846, 205 USPQ 1069, CCPA 1980. In the instant case, both applications are drawn to antimicrobial compositions and it is thus considered obvious to combine the two. Thus the rejection is based upon teachings of the references themselves, not impermissible speculation nor unfounded assumptions.
Conclusion
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783