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, 3, 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lisitschew (US 2016/0361481 A1).
With regard to claim 1, Lisitschew discloses A leakage connector (Fig. 1) configured for attachment to an opening of a leakage collecting device (see Fig. 1 plate that the connector 1 is inserted into. The claim limitation is functional and therefore the leakage collecting device does not need to be explicitly taught or shown by the prior art) of a dialysis machine ([0003], [0024]), the leakage connector comprising: a monolithic leakage adapter (1) comprising: a main body (1); a mounting plate (10) having a contact surface (generally at 16 as shown in Fig. 2) extending to an outer perimeter o the mounting plate, and a leakage inlet (2) formed in the contact surface at a location within the outer perimeter of the mounting plate and a leakage outlet (either of 4 or 6) interconnected with the leakage inlet via a channel (see bottom Fig of Fig. 1 showing the lumens within 2, 4, and 6) formed through the main body, and a seal (12/14) on the contact surface and surrounds the leakage inlet (best seen in Fig. 2 element 12 is connected to and contacts the contact surface 16).
With regard to claim 3, Lisitschew discloses wherein the monolithic leakage adapter comprises a sleeve (see annotated Fig below) extending from the main body, and the leakage outlet is formed at an end of the sleeve.
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With regard to claim 5, Lisitschew discloses wherein the contact surface extends in a plane, and the channel is inclined or slanted with respect to the plane (see annotated drawing below).
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With regard to claim 6, Lisitschew discloses wherein the channel comprises a bending or angulation (see Fig above).
With regard to claim 7, Lisitschew discloses a leakage construction for or of a dialysis machine comprising: a leakage connector according to claim 1 (see rejection above); and a chamber (see annotated drawing below) having a side wall comprising an opening (see annotate drawing below), the leakage connector being attached to the chamber with the leakage inlet adjacent to the opening (see Fig. 1) and the seal surrounding the opening (see Fig. 1) in a sealing manner via a retaining device.
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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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lisitschew (US 2016/0361481 A1) in view of Bayard et al. (US 4,366,816).
With regard to claim 2, Lisitschew discloses the seal except for the PU seal.
Bayard teaches that a sealing member for a medical device can be a PU foam (Col 5, lines 55 to
Col 6, line 13).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the seal of Lisitschew with the PU foam as taught by Bayard because the substitution of one seal material for another is well-known in the art and does not alter the overall function of the device (Col 5, line 55 to Col 6, line 13).
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vinci et al. (US 2010/0300945 A1) in view of Lisitschew (US 2016/0361481 A1).
With regard to claim 13, Vinci discloses A dialysis machine (Fig. 1) comprising: a leakage construction having: a leakage connector (see at 114a in Fig. 5); and a leakage collecting device (111, shown in Fig. 5) comprising an opening (where 111 connects with 114), the leakage connector being attached to the opening (at 114) in a sealing manner via a retaining device (114, [0068]); and a leakage detector (108) connected to the leakage construction.
However, Vinci does not disclose all the details of the leakage connector according to claim 1.
Lisitschew teaches the claimed leakage connector according to claim 1 as seen above.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Vinci with the specific connector as taught by Lisitschew for the purpose of providing a safer way to connect hoses of a dialysis machine ([0024]).
With regard to claim 14, Vinci disclose wherein: the opening is arranged at a lowest point of the leakage collecting device (where 114 connects to 111 is at the bottom of the container 111), the leakage outlet (113b) of the leakage adapter is arranged below the leakage inlet (113a) of the leakage adapter, the leakage detector (108) is arranged below the leakage outlet, and the leakage detector is connected to the leakage adapter via a monotonically descending hose (see fig. 6).
With regard to claim 15, Vinci discloses wherein: the opening (where 114 and 111 meet) is arranged at a lowest point of the leakage collecting device (see Fig.5), the leakage outlet (113b) of the leakage adapter is arranged below the leakage inlet (113a) of the leakage adapter, the leakage detector (108) is arranged below the leakage outlet (see Fig.6), and the leakage detector is arranged below an exit of a monotonically descending hose (see Fig. 6).
With regard to claim 16, Vinci discloses Vinci discloses A dialysis machine (Fig. 1) comprising: a leakage construction having: a leakage connector (see at 114a in Fig. 5); and a leakage collecting device (111, shown in Fig. 5) comprising an opening (where 111 connects with 114), the leakage connector being attached to the opening (at 114) in a sealing manner via a retaining device (114, [0068]); and a leakage detector (108) connected to the leakage construction, wherein: the opening is arranged at a lowest point of the leakage collecting device (where 114 connects to 111 is at the bottom of the container 111), the leakage outlet (113b) of the leakage adapter is arranged below the leakage inlet (113a) of the leakage adapter, the leakage detector (108) is arranged below the leakage outlet, and the leakage detector is connected to the leakage adapter via a monotonically descending hose (see fig. 6).
However, Vinci does not explicitly disclose the exact leakage connector.
Lisitschew discloses A leakage connector (Fig. 1) configured for attachment to an opening of a leakage collecting device (see Fig. 1 plate that the connector 1 is inserted into. The claim limitation is functional and therefore the leakage collecting device does not need to be explicitly taught or shown by the prior art) of a dialysis machine ([0003], [0024]), the leakage connector comprising: a monolithic leakage adapter (1) comprising: a main body (1); a mounting plate (10) having a contact surface (generally at 16 as shown in Fig. 2) extending to an outer perimeter o the mounting plate, and a leakage inlet (2) formed in the contact surface at a location within the outer perimeter of the mounting plate and a leakage outlet (either of 4 or 6) interconnected with the leakage inlet via a channel (see bottom Fig of Fig. 1 showing the lumens within 2, 4, and 6) formed through the main body, and a seal (12/14) on the contact surface and surrounds the leakage inlet (best seen in Fig. 2 element 12 is connected to and contacts the contact surface 16).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Vinci with the specific connector as taught by Lisitschew for the purpose of providing a safer way to connect hoses of a dialysis machine ([0024]).
With regard to claim 17 and 18, Vinci discloses the claimed invention except for the details of the leakage adapter.
Lisitschew teaches wherein the contact surface (see annotated drawing above) faces an adjacent surface of the side wall (see annotated drawing above labeled with chamber side wall), the contact surface and the adjacent surface have matching shapes and are planar (they are both on the same plane) (The opening of the chamber side wall and the contact surface are both circular shapes).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Vinci with the specific connector as taught by Lisitschew for the purpose of providing a safer way to connect hoses of a dialysis machine ([0024]).
With regard to claim 19, Vinci discloses the claimed invention except for the specific leakage adapter.
Lisitschew discloses wherein the seal (16) is adjacent to the leakage inlet (2) and spaced away from the outer perimeter of the mounting plate (see Fig. 1 and 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Vinci with the specific connector as taught by Lisitschew for the purpose of providing a safer way to connect hoses of a dialysis machine ([0024]).
With regard to claim 20, Vinci discloses further comprising a leakage detector (108) attached in fluid communication with the leakage outlet (connected via receptable 111), wherein an entire flow path from the leakage inlet to the leakage detector consists of a monotonically descending passage (see Fig. 6).
Allowable Subject Matter
Claims 8-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-20 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.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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