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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 29, it is unclear if the first and second connectors each include a collar, or only include one collar between the two.
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, 3-6, 8, 10, 11, 13, 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (US 2005/0101939) in view of Wegener et al (US 2017/0252550).
Regarding claim 1, Mitchell discloses a system for establishing a sterile fluid connection between a first fluid processing set and a second fluid processing set comprising: a first connector 14 configured for attachment with a first fluid processing set (via 72); a second connector configured 12 for attachment with a second fluid processing set (via 32); said first connector including a housing (fig 1) having a receiver 60 at a distal end of said first connector, said receiver including an open end and defining a chamber configured to receive at least a portion of said second connector in liquid-tight engagement (figs 1 and 2); the first connector including an openable flow path (interior of body) with said first fluid processing set, wherein the openable path is configured to be opened by receiving at least a portion of the second connector (fig 2; openable path between openings 52 and 102 is configured to be opened by the first connector receiving at least a portion of the second connector).
While Mitchell substantially discloses the invention as claimed, it does not disclose a light source in proximity to said first and second connectors.
Wegener discloses a system which uses a light source 62 in proximity to first 22a and second 22b connectors to sterilize the connectors (¶35).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mitchell such that it includes a light source in proximity to said first and second connectors as taught by Wegener to kill or inactivate microorganisms.
Regarding claim 3, wherein said second connector includes an openable flow path with said second fluid processing set (figs 1 and 2, via translation of 40).
Regarding claim 4, wherein said first connector includes an attachment member 72 located at a proximal end of said first connector and configured to receive a tube of said first fluid processing set (fig 1).
Regarding claim 5, wherein said second connector includes an attachment member 32 configured to receive a tube of said second fluid processing set (fig 1).
Regarding claim 6, wherein said first connector includes a plunger 90 and a sealing member 98 movable along a central axis, and wherein said plunger of said first connector includes a distal end and an opening in the distal end (fig 1, other opening that is not 102).
Regarding claim 8, wherein said second connector includes a housing having a plunger 40 and (a) sealing member 50 movable within said housing (figs 1 and 2), and wherein said plunger of said second connector includes a distal end and an opening 52 in the distal end (fig 1).
Regarding claim 10, while Mitchell substantially discloses the invention as claimed, it does not disclose wherein said first connector housing and said second connector housing are made of a transparent material.
Wegener discloses the coupler is made of a material transparent to UV light to (¶30 and ¶37) to allow UV exposure to sterilize the inner fluid flow path.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mitchell such that said first connector housing and said second connector housing are made of a transparent material as taught by Wegener to allow for sterilization of the inner fluid flow path.
Regarding claim 11, while Mitchell substantially discloses the invention as claimed, it does not disclose said light source emits light of a wavelength selected to effectively sterilize said first and second connectors when said connectors are in liquid-tight engagement.
Wegener discloses a system which uses a light source 62 in proximity to first 22a and second 22b connectors to sterilize the connectors (¶35). The light source is of a wavelength to effectively sterilize the connectors when said connectors are in liquid-tight engagement (¶35-¶37).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mitchell such that said light source emits light of a wavelength selected to effectively sterilize said first and second connectors when said connectors are in liquid-tight engagement as taught by Wegener to allow for sterilization of the inner fluid flow path.
Regarding claim 13, while Mitchell substantially discloses the invention as claimed, it does not disclose an enclosed irradiation chamber configured to receive said first and second connectors and an actuator for activating said light source.
Wegener discloses an enclosed chamber (via housing 48 – fig 1 and ¶32) to receive said first 22a and second 22b connectors and an actuator for activating said light source (¶39 and ¶42).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mitchell such that it has an enclosed irradiation chamber configured to receive said first and second connectors and an actuator for activating said light source as taught by Wegener so that the UV light for sterilization is kept within the system (and away from a user) and so that the light source has a means of being turned on/off so that it is not constantly on (and thus extending its life).
Regarding claim 28, comprising a holding assembly 108/110 configured for receiving the first connector and the second connector (fig 2).
Regarding claim 29, wherein the first connector and the second connector include a collar (collar on pin 116, which is a narrowed portion just below enlarged head – which is collar included as part of first connector; collar 28 in which holding assembly is received by second connector in fig 2 when assembled), and wherein the holding assembly comprises a first holder 114 and a second holder 112, wherein the first holder and the second holder include a slot configured to receive the collar of the first connector and the second connector (figs 2 and 3).
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
Applicant argues Mitchell does not disclose or suggest actively sterilizing the connection site. The examiner is not persuaded as references are not read in a vacuum. One of ordinary skill in the art is aware of the danger of microorganisms being introduced in connectors and why Wegener would be applicable. Mitchell also discloses preventing air from entering either line when disconnected (¶5), expressing Mitchell’s desire to prevent adverse effects from external sources (and one of ordinary skill in the art would recognize that microorganisms are an external factor in connections). Further, Mitchell states the device relates to “aseptic connectors or couplings” (¶1), thus Mitchell is concerned at least partially with microorganisms.
Applicant argues Mitchell and Wegener use materially different flow-control systems. Mitchell uses direct connections (two-part system) while Wegener uses a three-part system. The examiner is not proposing modifying Mitchell with a three-part system, and the effects of a light source are not contingent upon a three-part flow-control system. One of ordinary skill in the art would appreciate that a light source as disclosed by Wegener will sterilize the connectors said light touches regardless of how the connectors interact with each other and is desirable for such effects.
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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