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 .
This office action is in response to applicant’s communication of 5/22/2024. Currently claims 1-20 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/24/2025 is being considered by the examiner.
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)(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) 1-4 and 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticpated by US 2013/0187381 to GUALA. (hereinafter, "GUALA").
Regarding Claim 1, Guala discloses a connector (a valve connector 1 for medical lines; Fig. 1; Para. [0029]), comprising: a connector body comprising: a proximal region, a distal region, a longitudinal axis extending between the proximal region and the distal region (the valve 1 having a tubular body 2 having a proximal region at an inlet head 6, a distal region ending in a male luer lock connector 8, and a longitudinal axis; Fig. 3; Paras. [0029], [0030]), a sidewall extending between the proximal region and the distal region, a fluid channel extending from the proximal region to the distal region, and a threaded surface on at least a portion of the sidewall in the distal region (the body 2 including an internally threaded hollow element 10 having a sidewall with a threaded surface, a fluid channel extending between the proximal and distal region; Fig. 3; Para. [0029]); and a collar coupled to distal region, the collar configured to (i) deform to permit engagement between the threaded surface and a medical device, and (ii) resist axial movement of the medical device once engaged with the threaded surface (an outer maneuvering sleeve 12 having elastically sprung legs 15 configured to deform and permit engagement between the internally threaded hollow element 10 and a complementary threads of a female luer lock connector, the maneuvering sleeve 12 allowing unidirectional rotation in the direction of the threads and prevents movement in the opposite direction thereby resisting axial removal of the female connector; Fig. 3; Paras. [0029]-[0032]).
Regarding Claim 2, Guala discloses the connector of claim 1, wherein the collar is rotatable with respect to the connector body (the maneuvering sleeve 12 is unidirectionally rotatable; Para. [0030]).
Regarding Claim 3, Guala discloses the connector of claim 1, wherein the collar has a restricted axial range of movement in a distal direction with respect to the connector body (the sleeve 12 having a restricted axial range of movement in a distal direction; Fig. 1).
Regarding Claim 4, Guala discloses the connector of claim 1, wherein the collar includes one or more retention elements, each retention element including a distal face and a proximal face, wherein the distal face is not parallel to the proximal face (the maneuvering sleeve 12 includes an axial portions 13, 14, the axial portion 13 having the sprung legs 15 with engagement teeth 16 on the ends thereof, each tooth 16 having non parallel proximal and distal faces; Fig. 3; Para. [0031]).
Regarding Claim 11, Guala discloses a medical assembly, comprising: the connector of claim 1; and the medical device threadably coupled to the connector (the valve 1, a female luer lock threadably connected to a male luer lock 8 of the valve 1; Paras. [0029]-[0030]).
Claim(s) 13, 14, and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticpated by US 2022/0296870 to Vernin.
Regarding Claim 13, Vernin discloses a medical assembly (a non-removable connection system 100; Paras. [0155], [0156]), comprising: a connector comprising: a proximal region, a distal region, a longitudinal axis extending between the proximal region and the distal region, a sidewall extending between the proximal region and the distal region, a fluid channel extending from the proximal region to the distal region, a threaded surface on at least a portion of the sidewall in the distal region (a first connector 1 comprising a tubular main body having a proximal end with a connection port 9 and a distal region with a coupling portion 2, a longitudinal axis extending between the port 9 and coupling portion 2, a collar 20 extending between proximal and distal regions including an internal lateral wall 20a with a thread 23, and an internal fluid channel 7; Fig. 2A; Paras. [0156], [0164]), and one or more retention elements coupled to the distal region (locking projections 24 on the internal lateral wall 20a of the collar 20; Fig. 2B; Para. [0168]); and a medical device comprising: an external threading configured to engage the threaded surface of the connector, a connecting tip configured to receive at least a portion of the fluid channel of the connector (a second connector 11 connecting directly to a medical machine 200, an external lateral wall 11a of the connector 11 including a thread 13 configured to engage the thread 23, and a coupling portion 12 configured to receive the coupling portion 2 of the first connector and the internal channel 7 of the first connector 1 in the internal channel 17 of the second connector 11; Fig. 2A; Para. [0158]-[0159], [0164]), and one or more locking elements configured to cooperatively engage the one or more retention elements to (i) permit rotational coupling of the connector to the medical device, and (ii) resist rotational decoupling of the connector and the medical device (locking projections 14 configured to engage locking projections 24 to permit rotation in an engagement direction of the threads 13, 23 and prevent rotation in a disengagement direction of the threads 13, 23; Fig. 2B; Para. [0168]). Regarding
Claim 14, Vernin discloses the medical assembly of claim 13, wherein each retention element including a distal face and a lateral face, wherein the distal face is not parallel to the lateral face (each projection 14 having a slide surface 14a and a locking surface 14b, the slide surface not parallel to the locking surface; Fig. 2B; Para. [0170]).
Regarding Claim 18, Venin discloses the medical assembly of claim 14, wherein cach locking element includes a ramped face and a side face, wherein the ramped face is configured to contact the distal face of at least one retention element to permit rotation between the connector and the medical device in a first direction (the projections 24 including a slide surface 24a and a locking surface 24b, the slide faces 14a, 24a configured to engage to permit engagement rotation; Para. [0170]).
Regarding Claim 19, Vernin discloses the medical assembly of claim 18, wherein the side face is configured to contact the lateral face of at least one retention element to prevent rotation between the connector and the medical device in a second direction opposite the first direction (the locking surfaces 14b, 24b configured to engage to prevent rotation in the disengagement direction opposite the engagement direction; Para. [0170]).
Regarding Claim 20, Vernin discloses the medical assembly of claim 13, wherein the medical device is a closed system transfer device (a fluid tight connection for transfer of fluid to a medical machine; Para. [0156]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0187381 to GUALA. (hereinafter, "GUALA").
Regarding Claim 5, Guala discloses the connector of claim 4. Guala fails to explicitly disclose wherein the distal face forms an angle with the longitudinal axis between 30 degrees and 45 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala such that the distal face forms an angle with the longitudinal axis between 30 degrees and 45 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation being to assist in guiding the teeth into engagement when installed on the maneuvering sleeve
Regarding Claim 6, Guala discloses the connector of claim 4. Guala fails to explicitly disclose wherein the proximal face forms an angle with the longitudinal axis between 70 degrees and 80 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Industrie such that the proximal face forms an angle with the longitudinal axis between 70 degrees and 80 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation being to increase the force required to disengage the spring legs of the maneuvering sleeve, thereby preventing disassembly of the connector.
Regarding Claim 7, Guala discloses the connector of claim 4. Guala fails to explicitly disclose wherein the proximal face forms an angle with the distal face between 55 degrees and 80 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala such that the proximal face forms an angle with the distal face between 55 degrees and 80 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation being to assist in guiding the teeth into engagement when installed on the maneuvering sleeve.
Regarding Claim 10, Guala discloses the connector of claim 1, wherein the collar is constructed from plastic (Para. [0031]). Guala fails to explicitly disclose wherein the collar is constructed from polypropylene. It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala such that the collar is constructed from polypropylene, since selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. The motivation being to provide a chemically resistant and low cost connector.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0296870 to Vernin.
Regarding Claim 15, Vernin discloses the medical assembly of claim 14. Vernin fails to explicitly disclose wherein the distal face forms an angle with the longitudinal axis between 100 degrees and 110 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Vernin such that the distal face forms an angle with the longitudinal axis between 100 degrees and 110 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation being to optimize the angles of the slide faces of the locking projections for smooth unidirectional rotation.
Regarding Claim 16, Vernin discloses the medical assembly of claim 14. Vernin fails to explicitly disclose wherein the lateral face forms an angle with the longitudinal axis between 80 degrees and 90 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Vernin such that the lateral face forms an angle with the longitudinal axis between 80 degrees and 90 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.The motivation being to optimize the angles of the locking faces of the locking projections to permit smooth unidirectional rotation.
Regarding Claim 17, Vernin discloses the medical assembly of claim 14. Vernin fails to explicitly disclose wherein the lateral face forms an angle with the distal face between 80 degrees and 90 degrees. It would have been obvious to one of ordinary skill in the art before the priority date to modify Vernin such that wherein the lateral face forms an angle with the distal face between 80 degrees and 90 degrees, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation being to optimize the angles of the locking and slide faces of the locking projections to permit smooth unidirectional rotation.
Claim(s) 8-9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0187381 to GUALA. (hereinafter, "GUALA") In view of US 2022/0296870 to Vernin.
Regarding Claim 8, Guala discloses the connector of claim 4. Guala fails to explicitly disclose wherein an inner surface of the sidewall in the distal region defines a first diameter, wherein the one or more retention elements includes a plurality of retention elements radially spaced around the collar, and wherein the plurality of retention elements define a second diameter therebetween less than the first diameter. Vernin teaches a non-removable connection system (abstract), wherein an inner surface of the sidewall in the distal region defines a first diameter, wherein the one or more retention elements includes a plurality of retention elements radially spaced around the collar, and wherein the plurality of retention elements define a second diameter therebetween less than the first diameter (locking projections 24 radially spaced about the inner surface 20a of a collar 20 form a diameter smaller than said inner surface; Figs. 2, 2A, 2B). It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala such that an inner surface of the sidewall in the distal region defines a first diameter, wherein the one or more retention clements includes a plurality of retention elements radially spaced around the collar, and wherein the plurality of retention elements define a second diameter therebetween less than the first diameter as taught by Vernin. The motivation being to provide for unidirectional sliding engagement with complementary locking surfaces, thereby preventing disengagement of the connector (Gambro Para. [0168]).
Regarding Claim 9, modified Guala discloses the connector of claim 8. Guala fails to explicitly disclose wherein the second diameter is between 55% and 65% of the first diameter. Vernin teaches the non-removable connection system (abstract). Vernin fails to explicitly disclose wherein the second diameter is between 55% and 65% of the first diameter. It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala modified such that the second diameter is between 55% and 65% of the first diameter. The motivation being to provide for optimal engagement between the locking projections of the collar and complementary locking projections.
Regarding Claim 12, Guala discloses the medical assembly of claim 11. Guala fails to explicitly disclose wherein the medical device is a closed system transfer device. Vernin teaches wherein the medical device is a closed system transfer device (a fluid tight connection for transfer of fluid to a medical machine; Para. [0156]).It would have been obvious to one of ordinary skill in the art before the priority date to modify Guala such that the medical device is a closed system transfer device as taught by Vernin. The motivation being to provide a medical device and connector which are fluid tight and which do not require a user to check connections after a first installation (Vernin Para. [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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