DETAILED ACTION
This is a non-final rejection in response to application filed 1/3/24. Claims 1-20 are currently pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mermelshtein et al. (US 2022/0288378) in view of Jones et al. (US 2019/0224468).
Regarding independent claim 1, Mermelshtein teaches a connector assembly comprising: a luer 102 having a first end and second end opposite the second end, the luer having a luer body 102 and a luer pin104 disposed within the luer body, the luer body being configured to axially move relative to the luer pin [0137], wherein the luer has a central axis extending through the first end and the second end; a catheter coupler 120 having an opening and a valve, the catheter coupler configured to couple to the luer such that at least a portion of the luer pin is disposed through the opening and into the valve to form a fluid pathway between the luer and the catheter coupler (see fig. 9); and a connector 110 coupled to the luer such that the luer body is at least partially disposed within the connector, the connector including an engaging arm 340 and the connector having an engaged position and a disengaged position and is configured to transition from the engaged position to the disengaged position in response to a pullout force exceeding a predetermined threshold force [0160-0170], wherein in the engaged position the engaging arm is disposed proximate the central axis to secure the catheter coupler to the luer to prevent decoupling of the luer from the catheter coupler, and in the disengaged position [0046-0047].
Mermelshtein fails to teach the engaging arm is pivoted away from the central axis to allow the luer to decouple from the catheter coupler.
Jones teaches the engaging arm is pivoted away from the central axis to allow the luer to decouple from the catheter coupler [0059-0060].
It would have been obvious to one of ordinary skill in the art at the time of filing to provide Mermelshtein with pivoting engaging arms as taught by Jones as a simple substitution of one known element (in this case, snap-fit arms) for another (in this case, pivoting arm geometry) to obtain predictable results (in this case, a breakaway luer assembly with calibrated release and automatic sealing) was an obvious extension of prior art teachings, KSR, MPEP 2141 III B.
Regarding dependent claim 2, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches further comprising: a housing 300 having an opening and coupled to the luer such that the luer pin extends through the opening and the luer body is proximate the opening.
Regarding dependent claim 3, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the connector includes a base disposed opposite a distal end of the engaging arm, the base coupled to the housing (see fig. 9C, [0161].
Regarding dependent claim 4, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein the connector includes a connecting arm 122 coupling the base 121 to the engaging arm [0046], the connecting arm having a contracted position and an expanded position and biased to be in the contracted position [0059].
Regarding dependent claim 5, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein in the engaged position the connecting arm is in the contracted position and in the disengaged position, the connecting arm is in the expanded position [0058-0059].
Regarding dependent claim 6, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein, in the disengaged position, the connecting arm is in the expanded position and applies a pulling force on the engaging arm causing the engaging arm to pivot away from the central axis and away from the catheter coupler when the luer is coupled to the catheter coupler [0059-0060].
Regarding dependent claim 7, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the luer includes a biasing element disposed between the luer body and the luer pin, the biasing element biasing the luer body towards the opening of the housing [0158].
Regarding dependent claim 8, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the luer body includes a protrusion 170,270 extending from the luer body and the housing includes a cutout 340 sized and shaped to receive the protrusion, the cutout having a raised indent such that in the engaged position, the protrusion is disposed between the raised indent and the cutout and in the disengaged position the raised indent is disposed between the protrusion and the cutout [0126].
Regarding dependent claim 9, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein the raised indent increases the predetermined threshold force required for connector to transition from the engaged position to the disengaged position [0060-0063].
Regarding dependent claim 10, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the engaging arm includes a distal end proximate the first end of the luer, and in the engaged position, the distal end is proximate the central axis and in the disengaged position, the distal end is pivoted away from the central axis and away from the catheter coupler when the luer is coupled to the catheter coupler (see fig. 9A and 9C).
Regarding dependent claim 11, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein the connector includes a biasing arm 146 coupled to the engaging arm, the biasing arm configured to bias the distal end of the engaging arm to be proximate to the central axis [0057].
Regarding dependent claim 12, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein in view of Jones further teaches wherein the connector includes a biasing arm 146 (Jones) coupled to the engaging arm and the luer body includes a protrusion 170 (Mermelshtein), the protrusion disposed proximate the biasing arm and configured to apply a pushing force on the biasing arm when the pullout force exceeds the predetermined threshold force [0057].
Regarding dependent claim 13, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein, in response to the pullout force exceeding the predetermined threshold force, the luer body axial moves relative to the luer pin causing axial movement of the protrusion [0034-0035].
Regarding dependent claim 14, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the pullout force exceeding the predetermined threshold force causes axial movement of the luer body relative to the luer pin along the central axis [0015-0019].
Regarding dependent claim 15, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the pullout force exceeding the predetermined threshold force causes a portion of the connector to axially move relative to the luer pin [0015-0019].
Regarding dependent claim 16, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein the central axis bifurcates the luer, the connector, and the catheter coupler when the catheter coupler is coupled to the luer and the luer is at least partially disposed within the connector (fig. 9A-9C).
Regarding dependent claim 17, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Mermelshtein further teaches wherein in the disengaged position, the catheter coupler is configured to decouple from the luer causing the fluid pathway to be interrupted [0015-0019].
Regarding dependent claim 18, Mermelshtein in view of Jones teaches the invention as claimed and discussed above. Jones further teaches further comprising: a cover 127 disposed over the luer and the connector, the cover having a slot allowing access to the luer and the connector [0050].
Regarding independent claim 19, Mermelshtein in view of Jones teaches the invention as claimed and discussed above, as claim 19 is a combination of claims 1-7 and 14, the rejection of those limitations are presented above.
Regarding independent claim 20, Mermelshtein in view of Jones teaches the invention as claimed and discussed above, as claim 20 is a combination of claims 1-2,7-8 and 11-14, the rejection of those limitations are presented above.
Conclusion
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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