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 .
Claims 3, 9, 13, 15, 19, 21, and 26-28 are cancelled.
Claims 1, 2, 4-8, 10-12, 16-18, 20, and 22-25 are being examined in this Office Action.
Information Disclosure Statement
The information disclosure statement filed 4/15/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it appears a typographical error was made while inputting the Plishka reference, the publication number entered is "20080098407", however this publication number corresponds to Torrant et al. and is not relevant to the Application. It appears the publication number "20080097407" was meant to be entered instead, the Examiner has considered this reference. It has been placed in the application file. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 16-18, 20, and 29 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 16 and 17 recite the limitation “the second position” and “the flow path”, there is insufficient antecedent basis for these limitation in the claim. Examiner interprets “the second position” to mean when the male Luer connector and the female connector are engaged. Examiner interprets “the flow path” to be the previously recited “flow channel”.
Claim 17 additionally recites the limitation “the first position”, there is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the first position” to mean when the male Luer connector and the female connector are disengaged.
Claims 18 and 20 both recite the limitation “the moveable plunger member”, there is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation “a guide to allow the male Luer lock connector protrusion to advance a first axial distance in a first advance and restrict the advancement of the male Luer lock connector protrusion to a second axial distance shorter than the first axial distance in a second advance after the first advance”. This is confusing as it is unclear how a second advance restricts the male Luer lock connector protrusion to a second axial distance after the first advance. Examiner interprets that the guide allows the male Luer lock connector protrusion to advance a first axial distance before being restricted within a second axial direction from a single advance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, 7, 8, 10, 11, 12, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colman (Pub. No. US 20130345587 A1).
Regarding Claim 1, Colman discloses a small bore medical device connector (Fig. 3C) comprising:
a female connector (304’’) comprising a fluid path (318’’) and a receptacle (314’’) configured to accept a male Luer lock connector protrusion (302’’) extending from a male Luer lock connector (300’’, Fig. 3C), the female connector configured for threaded engagement to the male Luer lock connector (Fig. 3C, Paragraph [0126]),
wherein the male Luer lock connector protrusion of the male Luer lock connector comprises:
a standard Luer tapered protrusion extending continuously between a proximal portion and a distal portion of the male Luer lock connector protrusion (302’’ extending from 300’’ to 308’’ in Fig. 3C);
and a flow channel therewithin (310’’),
wherein the male Luer lock connector terminates at a tip disposed at the distal portion (360’’), the tip comprising an opening to the flow channel (Fig. 3C), and
wherein, when the female connector is threadedly engaged with the male Luer lock connector (at 320’’ and 322’’), a distal aspect of the tip of the male Luer lock connector protrusion contactingly engages a distal engagement surface (312’’) in the receptacle of the female connector to establish a fluid-tight seal and to establish fluid communication through a combined fluid pathway comprising the fluid path of the female connector and the flow channel of the male Luer lock connector (“Secondary male section 316'' has a sealing tip 370 at the part that is most remote from deepest point 312' of Luer female connector 304'. Sealing tip 370 is made of a material softer than that of secondary male section 316'' (it may be made of, for example, an O ring, a PVC ball or any other material which can be used for sealing)” – Paragraph [0126] to provide “essentially undisturbed gas flow” – Paragraph [0001]).
Regarding Claim 2, Colman discloses the small bore medical device connector of claim 1, wherein the female connector includes an external threading engagement portion (322’’) positioned externally of the receptacle (Fig. 3C), and the male Luer lock connector includes an interior threading portion (320’’) facing internally towards the male Luer lock connector protrusion (Fig. 3C), wherein the threadable engagement includes engagement of the external threading engagement portion with the interior threading portion (Paragraph [0131]).
Regarding Claim 4, Colman discloses the small bore medical device connector of claim 1, wherein the distal engagement surface in the receptacle is substantially perpendicular to a direction of axial advancement of the male Luer lock connector protrusion along a longitudinal axis of the male Luer lock connector protrusion during the threaded engagement (312’’ being perpendicular to direction of advancement of 302’’ along a longitudinal axis in Fig. 3C).
Regarding Claim 5, Colman discloses the small bore medical device connector of claim 1, wherein the receptacle comprises a recessed volume (314’’) defined by a wall (tapered wall of 304’’) and a base surface (312’’), the wall being substantially parallel to the standard Luer tapered protrusion of the male Luer lock connector when in the threaded engagement (Fig. 3C, Paragraphs [0127]-[0128]), the base surface being substantially parallel to the distal aspect of the tip (308’’) when the female connector and the male Luer lock connector are engaged (308’’ residing within 312’’ when engaged, Fig. 3C), the base surface comprising the distal engagement surface (Fig. 3C).
Regarding Claim 7, Colman discloses the small bore medical device connector of claim 1, wherein a geometry of the receptacle is configured such that when the male Luer lock connector is engaged, the distal aspect of the tip of the male Luer lock connector bottoms out against the distal engagement surface (308’’ residing within 312’’ when engaged, Fig. 3C).
Regarding Claim 8, Colman discloses the small bore medical device connector of claim 1 further comprising a sealing member (370’’) disposed in the receptacle (Fig. 3C), the sealing member configured to establish a fluid-tight seal when the distal aspect of the tip bottoms out against the distal engagement surface (Paragraph [0126]), wherein a geometry of the receptacle is adapted to form the fluid-tight seal between the distal aspect of the tip and the receptacle using the sealing member (Fig. 3C, Paragraph [0126]).
Regarding Claim 10, Colman discloses the small bore medical device connector of claim 1 further comprising a sealing member (370’’) disposed in the receptacle (Fig. 3C), wherein the sealing member includes the distal engagement surface (Fig. 3C).
Regarding Claim 11, Colman discloses the small bore medical device connector of claim 1, wherein the receptacle comprises a recessed volume (space within 314’’ when engaged in Fig. 3C) defined by a wall (316’’), the wall being substantially parallel to the standard Luer tapered protrusion of the male Luer lock connector when in threaded engagement with the female connector (Fig. 3C), wherein a tapered surface of the standard Luer tapered protrusion of the male Luer lock connector does not engage the wall to form a seal (316’’ does not engage with tapered portion of 326’’ when engaged, leaving a void within 314’’).
Regarding Claim 12, Colman discloses the small bore medical device connector of claim 1, wherein when the tip of the male Luer lock connector bottoms out at the distal engagement surface (308’’ bottoming out at 312’’ in Fig. 3C when in engagement), a fluid passageway is established between the standard Luer tapered protrusion of the male Luer lock connector and a wall (316’’) of the receptacle (fluid flow channels 310’’ and 318’’ in communication when in engagement in Fig. 3C).
Regarding Claim 16, Colman discloses the small bore medical device connector of claim 11, wherein, in the second position, the flow path comprises a section of the combined fluid pathway (310’’ combining when engaged with 318’’ to make the combined fluid pathway in Fig. 3C).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 Colman in view of Vedrine et al. (Pub. No. US 20150157810 A1, herein Vedrine).
Regarding Claim 6, Colman discloses the small bore medical device connector of claim 5.
Colman does not expressly disclose wherein a distance remains between the wall and the male Luer lock connector protrusion at all axial positions of a longitudinal axis of the male Luer lock connector protrusion when the distal aspect of the tip contactingly engages the distal engagement surface.
Vedrine teaches wherein a distance (region R in Fig. 6) remains between the wall (209) and the male Luer lock connector protrusion (641) at all axial positions of a longitudinal axis of the male Luer lock connector protrusion when the distal aspect of the tip contactingly engages the distal engagement surface (Fig. 6).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman wherein a distance remains between the wall and the male Luer lock connector protrusion at all axial positions of a longitudinal axis of the male Luer lock connector protrusion when the distal aspect of the tip contactingly engages the distal engagement surface as taught by Vedrine so that there may be a section of the connector that is separated from fluid communication with the fluid pathway (Vedrine, Paragraph [0152]).
Claim(s) 14, 17, 18, 20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of Ma (Pub. No. US 20140228778 A1).
Regarding Claim 14, Colman discloses the small bore medical device connector of claim 1.
Colman does not expressly disclose further comprising a moveable plunger member configured to actuate distally in response to an application of force by the tip of the male Luer lock connector to a top surface of the moveable plunger member when the male Luer lock connector is brought into threaded engagement with the female connector, the actuation translating the moveable plunger member from a first position in which the combined fluid pathway is closed to a second position in which the combined fluid pathway is open.
Ma teaches a moveable plunger member (10) configured to actuate distally in response to an application of force by the tip of the male Luer lock connector to a top surface of the moveable plunger member when the male Luer lock connector is brought into threaded engagement with the female connector (Fig. 2B, Paragraph [0033], connection of male Luer device 16 actuates septum actuator 10 to open fluid pathway), the actuation translating the moveable plunger member from a first position in which the combined fluid pathway is closed (Fig. 2A) to a second position in which the combined fluid pathway is open (Fig. 2B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman further comprising a moveable plunger member configured to actuate distally in response to an application of force by the tip of the male Luer lock connector to a top surface of the moveable plunger member when the male Luer lock connector is brought into threaded engagement with the female connector, the actuation translating the moveable plunger member from a first position in which the combined fluid pathway is closed to a second position in which the combined fluid pathway is open as taught by Ma so that there is a means of controlling fluid flow through the fluid pathway (Ma. Paragraph [0023]).
Regarding Claim 17, Colman discloses the small bore medical device connector of claim 11.
Colman does not expressly disclose wherein a distal opening of the flow path is sealed in the first position and open in the second position.
Ma teaches wherein a distal opening of the flow path is sealed in the first position (Fig. 2A, blood control septum 30 closed preventing fluid flow) and open in the second position (Fig. 2B, blood control septum 30 open while engaged with male Luer connector).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman wherein a distal opening of the flow path is sealed in the first position and open in the second position as taught by Ma so that there is a means of controlling fluid flow through the fluid pathway (Ma. Paragraph [0023]).
Regarding Claim 18, Colman discloses the small bore medical device connector of claim 11.
Colman does not expressly disclose the moveable plunger member further comprising a rod generally parallel to the fluid path, and wherein distal actuation of the moveable plunger member translates the rod through a sealed membrane causing the sealed membrane to rupture.
Ma teaches the moveable plunger member further comprising a rod (septum actuator 10 demonstrating rod shape, additionally “Septum actuator 10 may comprise various features to facilitate flow of fluid through blood control septum 30” – Paragraph [0024]) generally parallel to the fluid path (22, Fig. 2B), and wherein distal actuation of the moveable plunger member translates the rod through a sealed membrane (30) causing the sealed membrane to rupture (Fig. 2B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman further comprising a rod generally parallel to the fluid path, and wherein distal actuation of the moveable plunger member translates the rod through a sealed membrane causing the sealed membrane to rupture as taught by Ma so that there is a means of controlling fluid flow through the fluid pathway (Ma. Paragraph [0023]).
Regarding Claim 20, Colman discloses the small bore medical device connector of claim 11.
Colman does not expressly disclose the moveable plunger member further comprising a rod generally parallel to the fluid path, and wherein distal actuation of the moveable plunger member translates the rod to displace a plug and open the combined fluid pathway.
Ma teaches the moveable plunger member further comprising a rod (septum actuator 10 demonstrating rod shape, additionally “Septum actuator 10 may comprise various features to facilitate flow of fluid through blood control septum 30” – Paragraph [0024]) generally parallel to the fluid path (22, Fig. 2B), and wherein distal actuation of the moveable plunger member translates the rod to displace a plug (30, sealed membrane functioning as a plug to block the fluid pathway) and open the combined fluid pathway (Fig. 2B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman where the moveable plunger member further comprising a rod generally parallel to the fluid path, and wherein distal actuation of the moveable plunger member translates the rod to displace a plug and open the combined fluid pathway as taught by Ma so that there is a means of controlling fluid flow through the fluid pathway (Ma. Paragraph [0023]).
Regarding Claim 22, modified Colman in view of Ma discloses the small bore medical device connector of claim 14.
Modified Colman in view of Ma does not expressly disclose further comprising a biasing member disposed to return the moveable plunger member to the first position upon disengagement of the male Luer lock connector from the female connector.
However, in a differing embodiment, Colman teaches a biasing member (670, Fig. 6) disposed to return the moveable plunger member (650) to the first position upon disengagement of the male Luer lock connector from the female connector (“When the two connectors (primary Luer male connector 602 and primary Luer female connector 604) are mated, spring loaded tubular insert 650 is designed such that its top distal section is inserted into secondary female section 606 of the opposing connector (primary Luer male connector 602) at an early stage of the mating process, where any further pushing or screwing of the two connectors together will create force on spring 670, pushing spring loaded tubular insert 650 backwards.” – Paragraph [0173], when male Luer lock connector is not engaged with female connector, tubular insert 650 is not engaged and flow channel is separated, Fig. 6).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by modified Colman in view of Ma further comprising a biasing member disposed to return the moveable plunger member to the first position upon disengagement of the male Luer lock connector from the female connector as taught by the differing embodiment of Colman so that a continuous flow channel may be formed (Colman, Paragraph [0173]).
Regarding Claim 23, modified Colman in view of Ma discloses the small bore medical device connector of claim 22, wherein the biasing member is at least partially positioned between the male Luer lock connector protrusion (Colman, 602) and the receptacle (Colman, 614 extending through opening 613 to which the spring 670 resides) when the female connector is threadedly engaged with the male Luer lock connector (Colman, when 602 is in engagement with 604 in Fig. 6).
Regarding Claim 24, Colman discloses the small bore medical device connector of claim 1.
Colman does not expressly disclose further comprising a piercing element movably disposed in the receptacle such that it is in a first position prior to the threaded engagement and is translated to a second position when in the threaded engagement.
Ma teaches a piercing element (10) movably disposed in the receptacle (Figs. 3A-B) such that it is in a first position prior to the threaded engagement (Fig. 5) and is translated to a second position when in the threaded engagement (Fig. 3B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman further comprising a piercing element movably disposed in the receptacle such that it is in a first position prior to the threaded engagement and is translated to a second position when in the threaded engagement as taught by Ma so that a piercing element may be able to open and close a fluid pathway (Ma, Paragraph [0024]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of Grimm et al. (Pub. No. US 20130338588 A1, herein Grimm).
Regarding Claim 25, Colman discloses the small bore medical device connector of claim 1.
Colman does not expressly disclose further comprising a vent comprising a secondary fluid pathway not in fluid communication with the combined fluid pathway when the female connector and male Luer lock connector are in threaded engagement.
Grimm teaches a vent (19) comprising a secondary fluid pathway (Fig. 1A) not in fluid communication with the combined fluid pathway (20, Fig. 1A) when the female connector (14) and male Luer lock connector (12) are in threaded engagement (Fig. 1A).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman further comprising a vent comprising a secondary fluid pathway not in fluid communication with the combined fluid pathway when the female connector and male Luer lock connector are in threaded engagement as taught by Grimm so that any air that is introduced into the connector is allowed to pass through the connector, while maintaining the liquid within the combined fluid pathway (Grimm, Paragraph [0038]).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of Lerner (Pub. No. US 20140039456 A1).
Regarding Claim 29, Colman discloses the small bore medical device connector of claim 1.
Colman does not expressly disclose further comprising an auto-disable mechanism including a guide to allow the male Luer lock connector protrusion to advance a first axial distance in a first advance and restrict the advancement of the male Luer lock connector protrusion to a second axial distance shorter than the first axial distance in a second advance after the first advance.
Lerner teaches an auto-disable mechanism (Figs. 31A-C, Paragraph [0307]) including a guide (130) to allow a protrusion (126) to advance a first axial distance in a first advance (See annotated Fig. 31B below) and restrict the advancement of the male Luer lock connector protrusion to a second axial distance shorter than the first axial distance in a second advance after the first advance (Protrusion 126 restricted from further movement in annotated Fig. 31B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore medical device connector disclosed by Colman further comprising an auto-disable mechanism including a guide to allow the male Luer lock connector protrusion to advance a first axial distance in a first advance and restrict the advancement of the male Luer lock connector protrusion to a second axial distance shorter than the first axial distance in a second advance after the first advance as taught by Lerner so that a user may control the actuation of a needle (Lerner, Paragraph [0307]).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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