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 .
Specification
The disclosure is objected to because of the following informalities:
The reference character “115” has been used to refer to “coupler” in paragraph 0041, line 3 and “proximal port” in paragraph 0041, line 9.
Appropriate correction is required.
Claim Objections
Claims 1, 12 and 23 are objected to because of the following informalities:
Claim 1 recites the limitation “the proximal coupler” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the distal coupler” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the proximal coupler” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the distal coupler” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the second connector” in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the proximal coupler” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the distal coupler” in lines 10-11. There is insufficient antecedent basis for this limitation in the claim.
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 14-22 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.
Regarding claim 14, line 1, the recitation “a second connector” renders the claim indefinite because the claim is unclear if “a second connector” recited in claim 14 refers to “the second connector recited in claim 12 or additional. For examination purposes, examiner construes that “a second connector” refers to “the second connector” recited in claim 12.
Claims 15-22 being dependent on claim 14 are also rejected.
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.
Claims 1-9, 11-20 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et al. (US 2011/0040281 A1).
Regarding claim 1, White teaches an apparatus (figures 1, 4A-4D) comprising:
a connector (see “C” in figure 4A below) having:
a distal port (see “D” in figure 4A below) configured to be coupled to a hub (portion of element “170” that enables or connects to “D” in figure 4A below) of a catheter 170;
a proximal port (see “P” in figure 4A below);
a first lumen (hollow portion inside element “C” in figure 4A below, paragraph 0026, lines 12-27) extending between the distal port (see “D” in figure 4A below) and the proximal port (see “P” in figure 4A below), the lumen (hollow portion inside element “C” in figure 4A below) being in fluid communication with a second lumen (hollow portion inside element 170) defined by the catheter 170 when the distal port is coupled to the hub;
a side port (port in element “C” in figure 4A below that connects to one of two elements 140’) arranged in the connector (see “C” in figure 4A below) between the proximal coupler (coupler at element “P” in figure 4A below that enables connection to the needle, paragraph 0026, lines 12-27) and the distal coupler (coupler at element “D” in figure 4A below that enables connection to element 170), the side port configured to be in fluid communication with the first lumen (paragraph 0034, lines 1-3, in order to deliver the fluid to the element 170, port in element “C” in figure 4A below that connects to one of two elements 140’ has to be in fluid communication with hollow portion inside element “C” in figure 4A below); and
a fluid conduit (one of two elements 140’) having a proximal end (end of one of two elements 140’ in contact with element “C” in figure 4A below) coupled to the side port and a distal end (end of one of two elements 140’ in contact with element 120), the fluid conduit in fluid communication with the side port and configured to extend distally from the connector (see “C” in figure 4A below);
a stabilization platform 130 integrally formed with at least a part of the connector (see “C” in figure 4A below), the stabilization platform configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter (paragraph 0017, lines 12-17); and
an elongated arm (other of two elements 140’) configured to extend distally from the connector (see “C” in figure 4A below) or the stabilization platform 130.
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Regarding claim 2, White teaches wherein the elongated arm (other of two elements 140’) and the fluid conduit (one of two elements 140’) are configured to intersect one another at a location (location where element 120 is present i.e. where both elements 140’ comes in contact with element 180) distal to the distal port (see “D” in figure 4A above) of the connector (see “C” in figure 4A above).
Regarding claim 3, White teaches further comprising an anchor 120 configured to reversibly couple to the patient (paragraph 0021, lines 12-18).
Regarding claim 4, White teaches wherein the anchor 120 is coupled to the fluid conduit (one of two elements 140’).
Regarding claim 5, White teaches wherein the anchor 120 is arranged at an intersection of the elongated arm (other of two elements 140’) and the fluid conduit (one of two elements 140’).
Regarding claim 6, White teaches wherein the connector (see “C” in figure 4A above) comprises a second side port (port that allows communication with other of two elements 140’).
Regarding claim 7, White teaches further comprising a second fluid conduit 150 (associated with other of two elements 140’) coupled to the second side port (port that allows communication with other of two elements 140’).
Regarding claim 8, White teaches wherein the second fluid conduit 150 is configured to extend proximally from the second side port (see figure 5B where element 150 could be made to extend proximally from the second side port).
Regarding claim 9, White teaches wherein the elongated arm (other of two elements 140’) is a second fluid conduit (element 150 is located inside element 140’ and therefore element 140’ could be construed as a second fluid conduit) and is in fluid communication with the second side port.
Regarding claim 11, White teaches wherein the fluid conduit is coupled, at the distal end thereof, to a needless access connector 120).
Regarding claim 12, White teaches an apparatus (figures 1, 4A-4D) comprising:
a connector (see “C” in figure 4A above) having:
a distal port (see “D” in figure 4A above) configured to be coupled to a hub (portion of element “170” that enables or connects to “D” in figure 4A above) of a catheter 170;
a proximal port (see “P” in figure 4A above);
a first lumen (hollow portion inside element “C” in figure 4A above, paragraph 0026, lines 12-27) extending between the distal port (see “D” in figure 4A above) and the proximal port (see “P” in figure 4A above), the lumen (hollow portion inside element “C” in figure 4A above) being in fluid communication with a second lumen (hollow portion inside element 170) defined by the catheter 170 when the distal port is coupled to the hub;
a side port (port in element “C” in figure 4A above that connects to one of two elements 140’) arranged in the connector (see “C” in figure 4A above) between the proximal coupler (coupler at element “P” in figure 4A above that enables connection to the needle, paragraph 0026, lines 12-27) and the distal coupler (coupler at element “D” in figure 4A above that enables connection to element 170), the side port configured to be in fluid communication with the first lumen (paragraph 0034, lines 1-3, in order to deliver the fluid to the element 170, port in element “C” in figure 4A above that connects to one of two elements 140’ has to be in fluid communication with hollow portion inside element “C” in figure 4A below); and
a fluid conduit (one of two elements 140’) having a proximal end (end of one of two elements 140’ in contact with element “C” in figure 4A above) coupled to the side port and a distal end (end of one of two elements 140’ in contact with element 120), the fluid conduit in fluid communication with the side port and the second connector 120;
a stabilization platform 130 integrally formed with at least a part of the connector (see “C” in figure 4A above), the stabilization platform configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter (paragraph 0017, lines 12-17); and
an elongated arm (other of two elements 140’) configured to extend distally from the connector (see “C” in figure 4A above) or the stabilization platform 130.
Regarding claim 13, White teaches wherein the fluid conduit (one of the two elements 140’) is configured to extend proximally (see figure 5B where element 140’ could extend proximally) from the connector (see “C” in figure 4A above).
Regarding claim 14, White teaches further comprising a second connector 120 arranged at the distal end of the fluid conduit (one of two elements 140’).
Regarding claim 15, White teaches wherein the second connector 120 comprises a distal port (a port that connects to element 140’ in figure 4D) coupled to the distal end of the fluid conduit (one of two elements 140’), a proximal port (port in element 120 that connects to element 180), a third lumen (lumen extending inside element 120 between one of two elements 140’ and 180) between the distal port and the proximal port, and a side port (opening that allows communication with other of two elements 140’ in figure 4D) configured to be in fluid communication with the third lumen.
Regarding claim 16, White teaches further comprising a second fluid conduit 150 (associated with other of two elements 140’) having a proximal end (end of other of two elements 140’ connected to element 120) coupled to the second connector side port and a distal end (end of other of two elements 140’ connected to element 130), the second fluid conduit in fluid communication with the second connector side port, the second fluid conduit configured to extend distally (see figures 4D and 5B where element 140’ extension could be changed from element 120) from the second connector.
Regarding claim 17, White teaches wherein the elongated arm (one of two elements 140’) and the second fluid conduit (other of two elements 140’) are configured to intersect one another at a location (location where element 120 is present) distal to the distal portion (see “D” in figure 4A above) of the connector.
Regarding claim 18, White teaches further comprising an anchor (paragraph 0021, lines 12-18, “adhesive”, “straps” etc. could also act as anchor) configured to reversibly couple to the patient.
Regarding claim 19, White teaches wherein the anchor (paragraph 0021, lines 12-18, coupled via element 120) is coupled to the second fluid conduit.
Regarding claim 20, White teaches wherein the anchor (paragraph 0021, lines 12-18) is arranged at an intersection of the elongated arm and the second fluid conduit.
Regarding claim 23, White teaches a system (figures 1, 4A-4D) comprising:
a catheter 170; and
an adapter (entire structure shown in figures 1, 4A-4D except for element 170), the adapter comprising;
a connector (see “C” in figure 4A above) having:
a distal port (see “D” in figure 4A above) configured to be coupled to a hub (portion of element “170” that enables or connects to “D” in figure 4A above) of a catheter 170;
a proximal port (see “P” in figure 4A above);
a first lumen (hollow portion inside element “C” in figure 4A above, paragraph 0026, lines 12-27) extending between the distal port (see “D” in figure 4A above) and the proximal port (see “P” in figure 4A above), the lumen (hollow portion inside element “C” in figure 4A above) being in fluid communication with a second lumen (hollow portion inside element 170) defined by the catheter 170 when the distal port is coupled to the hub;
a side port (port in element “C” in figure 4A above that connects to one of two elements 140’) arranged in the connector (see “C” in figure 4A above) between the proximal coupler (coupler at element “P” in figure 4A above that enables connection to the needle, paragraph 0026, lines 12-27) and the distal coupler (coupler at element “D” in figure 4A above that enables connection to element 170), the side port configured to be in fluid communication with the first lumen (paragraph 0034, lines 1-3, in order to deliver the fluid to the element 170, port in element “C” in figure 4A below that connects to one of two elements 140’ has to be in fluid communication with hollow portion inside element “C” in figure 4A above); and
a fluid conduit (one of two elements 140’) having a proximal end (end of one of two elements 140’ in contact with element “C” in figure 4A below) coupled to the side port and a distal end (end of one of two elements 140’ in contact with element 120), the fluid conduit in fluid communication with the side port and configured to extend distally from the connector (see “C” in figure 4A above);
a stabilization platform 130 integrally formed with at least a part of the connector (see “C” in figure 4A above), the stabilization platform configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter (paragraph 0017, lines 12-17); and
an elongated arm (other of two elements 140’) configured to extend distally from the connector (see “C” in figure 4A above) or the stabilization platform 130.
Claim(s) 12, 14-16 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 2019/0366052 A1).
Regarding claim 12, Burkholz teaches an apparatus (figure 1) comprising:
a connector 101 having:
a distal port (port at element 103, figure 12) configured to be coupled to a hub 102 of a catheter 103;
a proximal port (port at element 107);
a first lumen (hollow portion inside element 101) extending between the distal port and the proximal port, the lumen being in fluid communication (see figure 2) with a second lumen (hollow portion inside element 103) defined by the catheter when the distal port is coupled to the hub;
a side port 105 arranged in the connector between the proximal coupler (coupling being located at element 107) and the distal coupler (coupling at element 103 enabling connection with element 103), the side port 105 configured to be in fluid communication with the first lumen (see figure 2); and a fluid conduit 108 having a proximal end (end of element 108 connected to element 105) coupled to the side port 105 and a distal end (other end of element 108), the fluid conduit in fluid communication with the side port and the second connector 305;
a stabilization platform 106 integrally formed with at least a part of the connector 101, the stabilization platform (paragraph 0084, element 106 could be used to contact the patient) configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter;
an elongated arm (see “A” in figure 12 below) configured to extend distally from the connector or the stabilization platform (element “A” in figure 12 below could be moved toward distal side of element 101 or 106 by bending element 105).
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Regarding claim 14, Burkholz teaches further comprising a second connector 305 arranged at the distal end of the fluid conduit 108.
Regarding claim 15, Burkholz teaches wherein the second connector 109 comprises a distal port (port of element 109 connected to element 108) coupled to the distal end of the fluid conduit 108, a proximal port (port of element 109 opposite to port of element 109 connected to element 108), a third lumen (hollow portion inside element 19) between the distal port and the proximal port, and a side port (port in element 109) configured to be in fluid communication with the third lumen.
Regarding claim 16, Burkholz teaches further comprising a second fluid conduit 302 having a proximal end (end of element 302 connected to element 109) coupled to the second connector side port (port in element 109) and a distal end (end of element 302 connected to element 303), the second fluid conduit 302 in fluid communication with the second connector side port (port in element 109), the second fluid conduit 302 configured to extend distally (element 302 could be moved distally with respect to element 109) from the second connector.
Regarding claim 22, Burkholz teaches wherein the second fluid conduit 302 is coupled, at the distal end thereof, to a needless access connector 303.
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) 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 2011/0040281 A1) in view of Roy (US 2016/0230914 A1).
Regarding claim 10, White discloses the claimed invention substantially as claimed, as set forth above in claim 1. White further discloses the connection of the fluid conduit with the element 120 but fails to disclose the type of connection and therefore, White is silent regarding wherein the fluid conduit comprises a luer adapter at the distal end thereof.
However, Roy teaches a design of a connector assembly comprising a luer adapter 100 or 200 (figure 1) for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the distal end of the fluid conduit of White to incorporate a luer adapter as taught by Roy for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Regarding claim 21, White discloses the claimed invention substantially as claimed, as set forth above in claim 12, 14, 15 and 16. White further discloses the connection of the second fluid conduit with the element “C” in figure 4A above but fails to disclose the type of connection and therefore, White is silent regarding wherein the second fluid conduit comprises a luer adapter at the distal end thereof.
However, Roy teaches a design of a connector assembly comprising a luer adapter 100 or 200 (figure 1) for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the distal end of the second fluid conduit of White to incorporate a luer adapter as taught by Roy for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783