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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that the claims are sufficiently related to allow for examination of these inventions together as they are related as a systems and method for establishing a sterile fluid connection. This is not found persuasive because that is still a broad category, presenting a serious search and examination burden to the examiner as the searches diverge and a reference applicable to one group is not necessarily applicable to the other group.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1-6, 8, 10, 11 and 13 are 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 1, line 3, it is unclear how “a first fluid processing set” is related to that on line 2. They are treated as the same. This confusion also results in an issue with “said first processing set” in claims 2 and 4 because it is unclear to which of the two referral is being made.
In claim 1, line 4, it is unclear how “a second fluid processing set” is related to that on line 2. They are treated as the same. This confusion also results in an issue with “said second processing set” in claims 3 and 5 because it is unclear to which of the two referral is being made.
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) 1-6, 8, 10, 11 and 13 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 12 configured for attachment with a first fluid processing set (via 32); a second connector configured 14 for attachment with a second fluid processing set (via 72); 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).
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 2, wherein said first connector includes an openable flow path between said receiver and said first fluid processing set (figs 1 and 2, via translation of 90).
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).
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.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783