DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the rejection of the claim(s) as being anticipated by Cabot have been considered but are moot because the new ground of rejection does not rely on the previously applied interpretation of Cabot. A new interpretation of the device as set forth in Cabot is set forth in the rejection below, which discloses the claimed invention.
Claim Objections
Claim 12 is objected to because of the following informalities: “a locking mechanism on a distal end of the introducer” should read “a locking mechanism on the distal end of the introducer”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 10, 12-14 and 16 of U.S. Patent No. 11,191,465 (‘465). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 is disclosed by claims 1 and 2 of ‘465 (introducer, catheter first/second positions, actuator in introducer lumen moved along its length, claim 2 adds the locking mechanism at the distal end portion), instant claim 2 is disclosed by claim 1 of ‘465 (actuator only remains partially in the lumen, so the remained is outside), instant claims 3 and 14 are disclosed by claim 1 of ‘465 (introducer defining a lumen receiving the catheter), instant claims 4 and 15 are disclosed by claims 5 and 10 of ‘465 (proximal end portion defines a port the catheter extends through), instant claims 9, 10 and 17 are disclosed by claim 14 of ‘465 (introducer defines a slot movably receiving a portion of the actuator), instant claim 11 is disclosed by claim 12 of ‘465 (catheter proximal end portion outside the introducer in both positions), instant claim 12 is disclosed by claims 12, 13 and 16 of ‘465 (locking mechanism coupling the introducer to the PIV, fixed-length introducer, catheter proximal end outside, the protruding length necessarily shortens as the actuator advances), instant claim 13 is disclosed by claim 1 (actuator moved along the length of the introducer) and instant claims 6 and 16 disclosed by claim 2 of ‘465 (locking mechanism).
Claims 1, 2, 4, 8-13, 15 and 17 Claims 1-4, 6, 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 9-11, 14, 17 and 19 of U.S. Patent No. 10,064,576 (‘576). Instant claim 1 is disclosed by claims 1 and 14 of ‘576, instant claim 2 is disclosed by claim 4 of ‘576, instant claims 4 and 15 are disclosed by claim 6 of ‘576, instant claim 8 is disclosed by claim 9 of ‘576, instant claims 9, 10 and 17 are disclosed by claim 11 of ‘576, instant claim 12 is disclosed by claims 16 and 17 of ‘576 and instant claim 13 is disclosed by claims 11 and 19 of ‘576.
Claims 1, 9, 10, 12, 13 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 9 and 18 of U.S. Patent No. 10,799,167 (‘167). Claim 1 of ‘167 discloses the actuator movable along a fixed length, claim 2 and claim of ‘167 disclose the slot, claim 5 and claim 9 of ‘167 disclose the lock at the introducer’s distal end coupling to the PIV port and claim 9 of ‘167 discloses the catheter disposed within and extending past the end of the PIV.
Claims 3, 6, 9, 10, 12-14, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9-11 of copending Application No. 17/519,968. Instant claim 1 is disclosed by claims 9 and 10 of the copending application, claim 9 recites the same preamble, the introducer with a locking mechanism at the distal end, and the catheter moveable from a first position with its distal end inside the introducer or the locking mechanism to a second position at least partially outside, claim 10 adds the actuator coupled to the catheter’s proximal end, movable along a fixed length of the introducer. Instant claims 6 and 16 are disclosed by claim 9 which sets forth the locking mechanism. Instant claims 9, 10 and 17are disclosed by claim 11 which claims an introducer that defines a slot, the actuator moveable in the slot along the fixed length. Instant Claim 12 is disclosed by claims 9 and 10, instant claim 13 is disclosed by claim 10, and instant claims 3 and 14 are disclosed by claim 9. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 6, 9, 10, 12-14, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 9-12 of copending Application No. 17/066,995. This is a provisional nonstatutory double patenting rejection. Instant claim 1 is disclosed by claims 9, 10 and 12 (introducer, catheter with first and second positions, actuator movable along a fixed length; claim 12 adds the lock at the introducer), instant claims 6 and 16 are disclosed by claim 12 (lock), instant claims 9, 10 and 17 are disclosed by claims 3 and 11 (introducer defines a slot, actuator movable within it along the fixed length), instant claim 12 is disclosed by claims 9, 10 and 12, instant claim 13 is disclosed by claim 2 and 10, instant claims 3 and 14 are disclosed by claims 1 and 9. This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the applicant, at the time the application was filed, did not have possession of the claimed limitation “or the locking mechanism of the introducer. At the time of filing, the specification never describes the catheter’s distal end sitting inside the locking mechanism in the first position. The closest passage is [0034] which describes locking mechanism 4131 at the distal end and 4122 at the proximal end “create an isolated housing for the catheter 4200 therein.” That’s the catheter inside the introducer between two locks, not inside a lock. Every other passage has the catheter moving through the locks’ seal once it opens ([0027], [0034]).
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 1-4 and 6-11 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 1, the limitation “within the introducer or the locking mechanism of the introducer” renders the claim indefinite. Because the locking mechanism is recited as part of the introducer, a catheter positioned within the locking mechanism is also positioned within the introducer. It is therefore unclear what additional subject matter the second alternative is intended to cover, and whether Applicant intends the locking mechanism to be a structure separate from the introducer. For purposes of examination the indefinite limitation has been deemed to claim that the structure is separate.
Regarding claims 1 and 12, the status of the peripheral intravenous line is unclear. The amendments to claims 1 and 12 moved the PIV line out of the body of the claim and into the preamble of the claim and functionally claiming the PIV line (the PIV line is not positively claimed in the preamble, as it is functionally claimed “for use” with the apparatus”. However, the body of the claim 1 states that a locking mechanism is configured to couple the introducer to the PIV line and the body of claim 12 states the catheter is provided separate from the PIV line. Therefore, it is unclear if the PIV is functionally claimed or a positively claimed element. For purposes of examination the indefinite limitation has been deemed to claim that the PIV in the preamble is intended to be positively claimed.
Regarding claims 1 and 12, the limitation “an apparatus for use with a PIV line configured to be at least partially insertable into a vein of a patient” renders the claim indefinite, It is unclear whether “configured to be at least partially insertable” modifies the PIV line or the apparatus. For purposes of examination the indefinite limitation has been deemed to claim that the modification is of the PIV line, not the apparatus.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 6 and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120191010 A1 to Cabot.
Regarding claim 1, Cabot discloses an apparatus for use with a peripheral intravenous line (placed catheter 104) configured to be at least partially insertable into a vein of a patient ([0028] “intravenous procedures… for use with veins in the arm and hand”), the apparatus comprising inter alia:
an introducer (male lock 116 and hollow needle 144, FIG. 6A) having a proximal end (the end of male lock 116 to which distal end 134 of protective sheath 130 is attached, [0059], FIGS. 5 and 6A) and a distal end (the free end of needle 144 opposite that proximal end, which pierces the resealable member of saline lock 122, [0062], FIG. 6A) wherein the distal end of the introducer includes a locking mechanism (the free end of needle 144, which couples to female Luer lock hub 118 on proximal end 120 of saline lock 122, [0062]) configured to couple the introducer to the peripheral intravenous line (saline lock 122 couples through male lock 126 on distal end 128 to female Luer lock hub 124 of placed catheter 104, [0058], FIG. 6A and 6B);
a catheter (collection catheter 102) defining a lumen between a proximal end of the catheter (proximal end 106) and a distal end of the catheter (distal end 136, [0056]), the catheter movable from a first position where the distal end of the catheter is at least partially positioned within the introducer (distal end 136 is nested within male lock 116, FIG. 5, as only distal end 136 extends beyond distal end 135 of protective sheath 130, [0060]) to a second position where the distal end of the catheter is at least partially positioned outside of the introducer (distal end 136 extends a distance beyond distal end 152 of placed catheter 104, [0063], FIG. 6B); and
an actuator (proximal end 132 of protective sheath 132) coupled to the catheter (proximal end 132 is fixedly coupled to proximal end 106 of catheter 102, [0059], FIG. 5), the actuator configured to move relative to the proximal end of the introducer to move the catheter between the first position and the second position (proximal end 132 is moved distally toward distal end 134 to move catheter 102 distally through needle 144, saline lock 122 and placed catheter 104, [0063], and distal end 134 is attached to the proximal end of male lock 116, [0059], FIG. 5, such that proximal end 132 moves relative to the proximal end of the introducer) wherein the actuator moves relative to the introducer in a direction extending parallel to a longitudinal axis of the introducer when the catheter moves from the first position to the second position (proximal end 132 moves distally along the longitudinal axis of male lock 116 and needle 144, FIG. 6A and 6B).
Regarding claim 2, Cabot discloses the apparatus of claim 1, wherein a portion of the actuator (proximal end 132) is positioned outside of the introducer (proximal end 132 is positioned proximal of, and outside, male lock 116 and needle 144, FIG. 6A and 6B).
Regarding claim 3, Cabot discloses the apparatus of claim 1, wherein the introducer includes a sheath (hollow needle 144) defining a lumen configured to receive at least a portion of the catheter (catheter 102 moves distally through needle 144, [0063], FIG. 6A).
Regarding claim 4, Cabot discloses the apparatus of claim 1, wherein the proximal end of the introducer includes a port (the opening at the proximal end of male lock 116), and wherein the catheter is received by the port (catheter 102 passes through the proximal end of male lock 116 to reach needle 144, FIGS. 5, 6A and 6B).
Regarding claim 6, Cabot discloses the apparatus of claim 1, wherein the locking
mechanism is a luer lock (the male Luer lock at the free end of needle 144, which couples to female Luer lock hub 118, [0062]).
Regarding claim 11, Cabot discloses the apparatus of claim 1, wherein the proximal end of the catheter (proximal end 116) is positioned outside of the introducer in the first position and the second position of the catheter (proximal end 106 is fixed to proximal end 132 of protective sheath 130, [0059], which remains proximal of distal end 134 and male lock 116 in both configurations, FIGS. 6A and 6B).
Regarding claim 12, Cabot discloses an apparatus for use with a peripheral intravenous line (placed catheter 104) configured to be at least partially insertable into a vein of a patient ([0028] “intravenous procedures… for use with veins in the arm and hand”), the apparatus comprising inter alia:
an introducer (male lock 116 and hollow needle 144, FIG. 6A) having a proximal end (the end of male lock 116 to which distal end 134 of protective sheath 130 is attached, [0059], FIGS. 5 and 6A) and a distal end (the free end of needle 144 opposite that proximal end, which pierces the resealable member of saline lock 122, [0062], FIG. 6A);
a catheter (collection catheter 102) defining a lumen between a proximal end of the catheter (proximal end 106) and a distal end of the catheter (distal end 136, [0056]), the catheter movable from a first position where the catheter is at least partially positioned within the introducer (distal end 136 is nested within male lock 116, FIG. 5, as only distal end 136 extends beyond distal end 135 of protective sheath 130, [0060]) to a second position where the distal end of the catheter is at least partially positioned outside of the introducer (distal end 136 extends a distance beyond distal end 152 of placed catheter 104, [0063], FIG. 6B), the catheter being provided separate from the peripheral intravenous line (collection catheter 102 is separate from, and received within, placed catheter 104, [0056]);
an actuator (proximal end 132 of protective sheath 132) coupled to the catheter (proximal end 132 is fixedly coupled to proximal end 106 of catheter 102, [0059], FIG. 5), the actuator configured to move relative to the proximal end of the introducer to move the catheter between the first position and the second position (proximal end 132 is moved distally toward distal end 134 to move catheter 102 distally through needle 144, saline lock 122 and placed catheter 104, [0063], and distal end 134 is attached to the proximal end of male lock 116, [0059], FIG. 5, such that proximal end 132 moves relative to the proximal end of the introducer); and
a locking mechanism (the male Luer lock at the free end of needle 144) on a distal end of the introducer and configured to fluidically couple the peripheral intravenous line to the introducer and place the catheter into fluid communication with the peripheral intravenous line (the male Luer lock couples to female Luer lock hub 118 on proximal end 120 of saline lock 122, which couples through male lock 126 on distal end 129 to female Luer lock hub 124 of placed catheter 103, after which external source 110 is actuated to transfer fluid from the body through catheter 102 to external source 110, [0058], [0062], [0064], FIGS. 6A and 6B), wherein a protruding portion of the catheter (the length of catheter 102 extending proximally of the proximal end of male lock 116) extends from the proximal end of the introducer, the protruding portion having a first length when the catheter is in the first position and a second length when the catheter is in the second position, and wherein the second length is smaller than the first length (as proximal end 132 is moved distally, catheter 102 advances through male lock 116 and needle 144 and protective sheath 130 collapses, reducing the length of catheter 102 proximal of the proximal end of male lock 116, [0061], [0063], FIGS 6A and 6B).
Regarding claim 13, Cabot discloses the apparatus of claim 12, wherein the actuator (proximal end 132) moves relative to the introducer in a direction extending parallel to a longitudinal axis of the introducer when the catheter moves from the first position to the second position (proximal end 132 moves distally along the longitudinal axis of male lock 116 and needle 144, [0063], FIGS 6A and 6B).
Regarding claim 14, Cabot discloses the apparatus of claim 12, wherein the introducer includes a sheath (hollow needle 144) defining a lumen configured to receive at least a portion of the catheter (catheter 102 moves distally through needle 144, [0064], FIG. 6A).
Regarding claim 15, Cabot discloses the apparatus of claim 12, wherein the proximal end of the introducer includes a port (the opening at the proximal end of male lock 116)), and wherein the catheter is received by the port (catheter 102 passes through the proximal end of male lock 116 to reach needle 144, FIGS. 5, 6A and 6B).
Regarding claim 16, Cabot discloses the apparatus of claim 12, wherein the locking mechanism is a Luer lock (the male Luer lock at the free end of needle 144, which couples to female Luer lock hub 118, [0062]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabot in view of US 2012/0277630 A1 to Devgon.
Cabot discloses the claimed invention as set forth and cited above in Claim 1, except for expressly disclosing where the catheter is between 16 gauge and a 26 gauge and wherein the catheter has a Shore durometer of 20 Shore A to 50 Shore D. However, Devgon teaches at paragraph [0028] that a catheter between a 16 to 26 gauge with a Shore durometer of 20 Shore A to 50 Shore D would be sufficiently stiff to be advanced through a peripheral intravenous line. Therefore, a skilled artisan would have found the modification of the catheter of Cabot to have the Shore durometer of Devgon, as Devgon teaches that stiffness of a catheter for the successful advancement through a peripheral intravenous line.
Allowable Subject Matter
Claims 9 is 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 (e.g., claim 1) and any intervening claims.
Claims 19 is 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 (e.g., claim 12)) and any intervening claims (e.g., claim 13).
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
