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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 11, 12 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lopez et al (2011/282302 A1).
As to claims 1 and 15, Lopez et al disclose a connection system, comprising: a male connector (95 including 92/110/118) associated with a single patient-use ("SPU") medical device (212), the male connector including a flexible member (60) around the male connector with the flexible member proximal of a plug of the male connector (figs 6-7); and a female connector (204) associated with a multiple patient-use ("MPU") medical device (200; [0050]), the female connector including a rigid member (211) around an opening of a receptacle of the female connector (figs 6-7; [0078; 105; 110], and the flexible member configured to conform to the rigid member with a procedural barrier (63; fig 6) therebetween when the plug of the male connector is inserted into the receptacle of the female connector, thereby establishing one or more functional connections across the procedural barrier between the SPU and MPU medical devices [0049].
As to claim 2, Lopez et al disclose the connection system of claim 1, wherein the flexible member is fixedly coupled to the male connector (at least a portion of the seal 60 remains coupled [0071]).
As to claim 3, Lopez et al disclose the connection system of claim 1, wherein the flexible member is removably coupled to the male connector(at least a portion of the seal 60 is removeable [0071]).
As to claim 4, Lopez et al disclose the connection system of claim 1, wherein the flexible member is a flexible disk (36).
As to claim 5, Lopez et al disclose the connection system of claim 1, wherein the rigid member is fixedly coupled to the female connector (fig 1).
As to claims 7 and 17, Lopez et al disclose the connection system of claim 1, wherein the rigid member is a rigid bowl opening away from the receptacle of the female connector (figs 6-7).
As to claim 11, Lopez et al disclose connection system of claim 1, wherein the male connector is adherently secured to the female connector upon insertion of the plug of the male connector into the receptacle of the female connector via an adhesive over a mating surface of each member of the flexible and rigid member [0093].
As to claim 12, Lopez et al disclose the connection system of claim 1, wherein conformation of the flexible member to the rigid member forms a fluid-tight seal [0101].
As to claims 13 and 19, Lopez et al disclose the connection system of claim 1, wherein the one-or-more functional connections are selected from electrical, optical, and fluid connections [0049].
As to claim 16, Lopez et al disclose the method of claim 15, wherein the flexible member is a flexible disk (36) fixedly or removably coupled to the male connector (figs 6-7).
As to claim 18, Lopez et al disclose the method of claim 15, wherein the male connector is magnetically, mechanically, or adherently secured to the female connector upon insertion of the plug of the male connector into the receptacle of the female connector, conformation of the flexible member to the rigid member forming a fluid-tight seal [0093].
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez et al (2011/282302 A1).
As to claim 6, Lopez et al disclose the claimed invention except for wherein the rigid member is removably coupled to the female connector. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make the rigid member removably coupled to the female connector, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez et al (2011/282302 A1) in view of Hebert et al (US 2021/0236795 A1).
As to claims 8-10, Lopez et al disclose the invention substantially as claimed for the connection system of claim 1, however fails to explicitly disclose a magnetic or mechanical coupling. Hebert et al disclose the wherein the male connector is magnetically secured to the female connector upon insertion of the plug of the male connector into the receptacle of the female connector via one or more magnets in each member of the flexible member and the rigid member [0096]; wherein a male connector is mechanically secured to female connector upon insertion of the plug of the male connector into the receptacle of the female connector via one or more retractable protrusions protruding from the plug of the male connector and one or more corresponding recesses in an inner wall of the receptacle [0096]; wherein the one-or-more retractable protrusions and the one-or-more corresponding recesses produce an audible click-type sound upon the insertion of the plug of the male connector into the receptacle of the female connector, thereby indicating the male connector is mechanically secured to the female connector [0096]. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Lopez et al. with the locking mechanisms as taught by Hebert et al for the purpose of securing a male and female luer [0096].
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez et al (2011/282302 A1) in view of Cohen et al (US 2019/0083193 A1).
As to claims 14 and 20, Lopez et al disclose the invention substantially as claimed for the connection system of claim 1, however fails to disclose wherein the procedural barrier is a sterile drape such that the one-or-more functional connections across the procedural barrier between the SPU and MPU medical devices extend from a sterile field including the SPU medical device and a non-sterile field including the MPU medical device. Cohen et al disclose wherein the procedural barrier is a sterile drape (304) such that the one-or-more functional connections across the procedural barrier between the SPU and MPU medical devices extend from a sterile field including the SPU medical device and a non-sterile field including the MPU medical device (fig 3A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Lopez et al with the drape as taught by Cohen et al for the purpose of separating between sterile and non-sterile components to maintain sterility during surgical procedures [0091].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Leinsing et al (US 2007/0007478 A1) disclose a connector.
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/IMANI N HAYMAN/ Supervisory Patent Examiner, Art Unit 2841