DETAILED ACTION
This is a final rejection in response to application filed 7/10/26. Claims 1-4, 6-11, and 13-20 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-11, and 13-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 9 recites the limitation " force required for connector to transition”. This should read ”force required for the connector to transition”.
Claim 13 recites the limitation " the luer body axial moves”. This should read” the luer body axially moves”.
Appropriate correction is required.
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 6, 19-20 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.
Claim 6 recites the limitation "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 ". Previously in claim 1, the claim recites the limitation “wherein the connector is configured to transition from an engaged position to a disengaged position in response to a pullout force that causes the protrusion to apply a pushing force to the biasing arm, the pullout force exceeding a predetermined threshold force, wherein in the engaged position, the engaging arm is disposed proximate the central axis to secure the catheter coupler to the luer to prevent movement of the luer from relative to the catheter coupler, and in the disengaged position, the engaging arm is pivoted away from the central axis by the pushing force on the biasing arm to allow the luer to decouple from the catheter coupler.” It is unclear if the pivoting is caused by the pushing force on the biasing arm or the pulling force from the connecting arm.
Claim 19 recites the limitation "a plurality of engaging arms” and later recites “pivoting the plurality of engagement arms”. It is unclear if engagement arms is a new set of arms or meant to refer to the previously recited “plurality of engaging arms”.
Claim 19 recites the limitation "a biasing member” and later recites “the biasing element”. It is unclear if the biasing element is a new limitation or meant to refer to the previously recited biasing member”.
Claim 20 recites the limitation "wherein the luer includes a biasing element disposed between the luer body and the luer pin and a protrusion extending from the luer body”. Previously, “a biasing element disposed between the luer body and the luer pin” and “one or more protrusions extending from the luer body” were claimed, it is unclear if the same element is being restated or if an additional element is being claimed.
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) 1-4, 6, 10-11, 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour er al. (US 2017/0007816) in view of Jones et al. (US 2017/0067586).
Regarding independent claim 1, Mansour teaches a connector assembly comprising: a luer 108 having a first end (near inlet port 104), a second end (near outlet port 106) opposite the second first end, the luer having a luer body 102, a protrusion 114 disposed on the luer body, and a luer pin 152 disposed within the luer body, the luer body being configured to axially move relative to the luer pin [0035], wherein the luer has a central axis 112 extending through the first end and the second end; a catheter coupler 900 having an opening 902 and a valve 908 at least partially disposed within the opening, 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 [0035]; and a connector 120,130,160 coupled to the luer such that the luer body is at least partially disposed within the connector [0025], the connector including: a connecting arm 160; an engaging arm 120 coupled to the connecting arm; and a biasing arm 525 coupled to the engaging arm [0048], wherein in the engaged position, the engaging arm is disposed proximate the central axis to secure the catheter coupler to the luer to prevent movement of the luer relative to the catheter coupler [0029-0036], and in the disengaged position, the engaging arm is pivoted away from the central axis by the pushing force on the biasing arm to allow the luer to decouple from the catheter coupler [0036,0048].
Mansour fails to teach wherein the connector is configured to transition from an engaged position to a disengaged position in response to a pullout force that causes the protrusion to apply a pushing force to the biasing arm, the pullout force exceeding a predetermined threshold force.
Jones teaches wherein the connector is configured to transition from an engaged position to a disengaged position in response to a pullout force that causes the protrusion to apply a pushing force to the biasing arm, the pullout force exceeding a predetermined threshold force [0059-0063].
It would have been obvious to one of ordinary skill in the art at the time of filing to provide Mansour 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, Mansour in view of Jones teaches the invention as claimed and discussed above. Jones further teaches further comprising: a housing 24 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, Mansour in view of Jones teaches the invention as claimed and discussed above. Jones further teaches wherein the connector includes a base disposed opposite a distal end of the engaging arm, the base coupled to the housing [0025-0026].
Regarding dependent claim 4, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour further teaches wherein the connecting arm has a contracted position and an expanded position and is biased to be in the contracted position [0026-0027].
Regarding dependent claim 6, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour 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 [0026-0027, claim 6 of Mansour].
Regarding dependent claim 10, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour 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 [0025,0029,0034].
Regarding dependent claim 11, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour further teaches wherein the biasing arm is configured to bias the distal end of the engaging arm to be proximate to the central axis (Claim 13 of Mansour).
Regarding dependent claim 13, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour 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 (Claim 12 of Mansour).
Regarding dependent claim 14, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour 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 (Claim 12 of Mansour).
Regarding dependent claim 15, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour 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 [0026-0027].
Regarding dependent claim 16, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour further teaches wherein the central axis bifurcates the luer 102, the connector 120, and the catheter coupler 900 when the catheter coupler is coupled to the luer and the luer is at least partially disposed within the connector [0025,0034].
Regarding dependent claim 17, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour further teaches wherein in the disengaged position, the catheter coupler is configured to decouple from the luer causing the fluid pathway to be interrupted [0035-0036].
Regarding dependent claim 18, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour further teaches further comprising: a cover 127 disposed over the luer and the connector, the cover having a slot 138 allowing access to the luer and the connector.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour in view of Jones and further in view of Fangrow et al. (US 2014/0303601).
Regarding dependent claim 7, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour in view of Jones fails to teach 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.
Fangrow 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 [0136].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Mansour in view of Jones with the biasing element of Fangrow, as Fangrow teaches biasing the luer connector ensures a sealed, non-leaking configuration [0136].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour in view of Jones and further in view of Jones et al. (US 2017/0067586).
Regarding dependent claim 8, Mansour in view of Jones teaches the invention as claimed and discussed above. Mansour teaches wherein the protrusion 114 extends from the luer body 102, and the housing includes a cutout sized and shaped to receive the protrusion [0025]. Mansour in view of Jones fails to teach 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.
Jones ‘586 teaches it was known to have 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 ([0058], raised interference feature, clasp 152, within the housings receiving structure sits on opposite sides of the mating protrusion 154).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Mansour in view of Jones with the raised indent and cutout as discussed in Jones ‘586. Jones ‘586 teaches such a feature is used to set and resist axial pullout [0058].
Regarding dependent claim 9, Mansour in view of Jones and further in view of Jones ‘586 teaches the invention as claimed and discussed above. Jones ‘586 further teaches wherein the raised indent increases the predetermined threshold force required for connector to transition from the engaged position to the disengaged position [0058].
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour in view of Jones ’586 and further in view of Fangrow and further in view of Jones.
Regarding independent claim 20, Mansour teaches a connector assembly comprising: a luer 108 having a first end (near inlet port 104), a second end (near outlet port 106) opposite the second first end, the luer having a luer body 102, a protrusion 114 disposed on the luer body, and a luer pin 152 disposed within the luer body, the luer body being configured to axially move relative to the luer pin [0035], wherein the luer has a central axis 112 extending through the first end and the second end; a catheter coupler 900 having an opening 902 and a valve 908 at least partially disposed within the opening, 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 [0035]; and a connector 120,130,160 coupled to the luer such that the luer body is at least partially disposed within the connector [0025], the connector comprising:
a base 102 coupled to the housing;
a plurality of engaging arms 120,130 each coupled to the base via a plurality of connecting arms 160;
wherein the connector is configured to transition from an engaged position to a disengaged position causing axial movement of the luer body relative to the luer pin and the housing along the central axis [0025-0026],
wherein in the engaged position, the plurality of connecting arms are contracted and the plurality of engaging arms are disposed proximate the central axis to secure the catheter coupler to the luer to restrict decoupling of the luer from the catheter coupler [0026-0027],
wherein in the disengaged position, the plurality of connecting arms are expanded, and the protrusions apply a pushing force to the plurality of biasing arms to pivot the plurality of engaging arms are pivoted away from the central axis to allow the luer to decouple from the catheter coupler [0027,0036].
Mansour fails to teach a biasing element disposed between the luer body and the luer pin, a housing 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, the biasing element biasing the luer body towards the opening, a plurality of biasing arms coupling the plurality of engaging arms together, the plurality of biasing arms configured to engage the one or more protrusions and wherein the connector is configured to transition from an engaged position to a disengaged position in response to a pullout force exceeding a predetermined threshold force with the protrusions apply a pushing force to the plurality of biasing arms.
Jones ‘586 teaches it was known to have a housing 24 having an opening 26 and coupled to the luer such that the luer pin 28 extends through the opening and the luer body is proximate the opening [0025-0026].
Fangrow 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 [0136].
Jones teaches the connector is configured to transition from an engaged position to a disengaged position in response to a pullout force exceeding a predetermined threshold force with the protrusions apply a pushing force to the plurality of biasing arms [0059-0063].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Mansour with the teachings of Jones ‘586, Fangrow, and Jones. Jones ‘586 housing would provide protection, Fangrow teaches biasing the luer connector ensures a sealed, non-leaking configuration [0136] and Jones teaches automatically seoarating before adhesive or securement devices fail as a matter of safety [0011].
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 CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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