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 § 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.
Claims 1 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2005/0054985 to Mogg in view of U.S. Patent No. 3,595,239 to Petersen and U.S. Patent Publication No. 2012/0172680 to Gelfand et al. (“Gelfand”).
Regarding claim 1, Mogg teaches a system for delivering a medicament to a target tissue site in a patient over a period of time, the system comprising a catheter (2) configured for implantation in a target tissue site (Fig. 1), the catheter extending from a proximal end to a distal end and having a sidewall which defines an internal lumen (lumen of catheter 2), a medicament reservoir fluidly communicable with the internal lumen of the catheter ([0003], continuous administration requires a reservoir), an adhesive member (7) configured to adhere to the skin of the patient around an exit wound and having an opening therein to allow the catheter to pass through the adhesive member (opening of 7, Fig. 1), a retaining member (1) configured to be overlaid on the adhesive member (Fig. 1) and comprising a guide surface (15) configured to receive a length of the catheter and a plurality of retaining portions (16) to retain the catheters against the guide surface, but does not teach the trocar and an aperture in the sidewall of the catheter.
Petersen teaches a nerve stimulating trocar (Fig. 2) comprising an elongate body (20), the nerve stimulating trocar configured to connect with the distal end of the catheter (Fig. 3) having one or more apertures (16) in the sidewall for a release of the medicament into the target tissue site, and to advance the catheter through the tissue of the patient to the target tissue site, wherein the nerve stimulating trocar comprises a nerve stimulator configured to stimulate the one or more nerves adjacent to the target tissue site (column 3, lines 16-24). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mogg to incorporate the nerve stimulating trocar/catheter of Petersen to yield the predictable result of providing a means of inserting a catheter into the body to a target location. Mogg shows a clamp for holding a catheter to treat the body and the catheter requires insertion into the body in order for the clamp to function; Petersen shows an obvious art-recognized example of how a catheter may be inserted. Regarding the stimulation being configured to elicit a neural response, given that the electrode of Peterson imparts electrical current, as would be understood by a skilled artisan, the application of electrical current upon a nerve would elicit a neural response, even if it is brief or at least by adjacent nerves that are not cut.
In any case, Gelfand has been cited to teach the alternative use of electrodes for either stimulation or perforation ([0141]), the stimulation electrodes being capable of eliciting a neural response in one or more nerves. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted a stimulating electrode for the electrode of Petersen as taught by Gelfand to yield the predictable result of providing an art-recognized alternative electrode to suit the particular need or purpose depending on the treatment required by the caregiver.
Regarding claim 11, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, Mogg further teaching the retaining member is a partially circular structure (Fig. 2) having a relatively planar base surface (5, Fig. 1) and wherein the guide surface is opposed to the planar base (Fig. 1) and is a curved surface (41, Fig. 2) which terminates in an outer rim (40).
Regarding claim 12, Mogg, Petersen, and Gelfand teach the system of claim 11 as shown above, Mogg further teaching the retaining member includes one or more clips (16 and portions of cap 3 opposite 16) to retain the catheter against the guide surface (Fig. 1).
Regarding claim 13, Mogg, Petersen, and Gelfand teach the system of claim 12 as shown above, Mogg further teaching the clips comprise a pair of opposed jaw members (16 and portions of cap 3 opposite 16) which together form a tunnel (14/15) therethrough.
Regarding claim 15, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, Mogg further teaching a retainer housing comprising a substantially circular base (26, Fig. 2) having an outer facing surface (top of 26) and a substantially flat inner surface (bottom of 26) and an outer rim (35/36) which extends peripherally from circular base and terminates in a lip ([0044]).
Regarding claim 16, Mogg, Petersen, and Gelfand teach the system of claim 15 as shown above, Mogg further teaching the retainer housing further comprises a plurality of arms (Fig. 2, upper and lower portions of 24) which extend centrally from an inner edge (27) of the circular base and which terminate in a central body (generally designated by 20).
Claims 2, 3, and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, and Gelfand as applied to claim 1 above, and further in view of U.S. Patent No. 5,090,408 to Spofford et al. (“Spofford”).
Regarding claim 2, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, but do not explicitly teach two or more catheters.
Spofford teaches the use of two or more catheters (column 5, lines 30-33). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used two catheters in the system of Mogg as taught by Spofford as a second catheter may be used to replace a first catheter for subsequent care (column 5, lines 32-33) and/or to yield the predictable result of replacing an old catheter that becomes damaged or when a different treatment type is required.
Regarding claim 3, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 2 as shown above, Petersen further teaching a trocar receiving opening in the sidewall at the distal end (another 16 separate from the aperture of claim 1 of the plural drainage openings, column 2, lines 18-20, which is capable of receiving a trocar) of the initial catheter and once modified by Spofford, two catheters would likewise have the trocar receiving opening.
Regarding claim 5, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 3 as shown above, Petersen further teaching the nerve stimulating trocar is configured to disconnect from the distal end of the catheter for withdrawal of the nerve stimulator from the target tissue site (column 2, lines 25-26).
Regarding claim 6, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 5 as shown above, Petersen further teaching the nerve stimulating trocar (20) comprises an elongate body having a proximal region, a distal region having a distal tip and an intermediate region between the proximal and distal regions (Fig. 2).
Regarding claim 7, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 6 as shown above, Petersen further teaching the nerve stimulating trocar comprises one or more electrodes (column 3, lines 16-17).
Regarding claim 8, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 7 as shown above, Petersen further teaching the one or more electrodes are at the distal tip of the nerve stimulating trocar (column 3, lines 16-18).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, and Gelfand as applied to claim 1 above, and further in view of U.S. Patent No. 4,784,156 to Garg.
Regarding claim 4, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, but do not teach a tunnelling trocar.
Garg teaches a tunnelling trocar, said tunnelling trocar having an elongate solid body which extends from a proximal end to a distal end (Fig. 10), the tunnelling trocar having a hook feature (77/78) at or adjacent to either the proximal or distal end. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the tunneling trocar of Garg into the system of Mogg, Petersen, and Gelfand to yield the predictable result of providing an alternative means of device insertion. The cutting needle of Garg is used to insert analogous outer tubular device such as 40 in Fig. 6 of Garg, and provides an alternative or supplement to the trocar of Petersen in providing a means of device insertion to suit the particular treatment application or physiology.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, Gelfand, and Spofford as applied to claim 6 above, and further in view of U.S. Patent No. 7,291,130 to McGurk.
Regarding claim 9, Mogg, Petersen, Gelfand, and Spofford teach the system of claim 6 as shown above including the nerve stimulating trocar but do not teach the bend.
McGurk teaches the intermediate region of the nerve stimulating trocar forms a bend such that a main axis of the proximal region is offset and substantially parallel to a main axis of the distal region (Fig. 1, far left tip). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tip design of the nerve stimulating trocar of Mogg, Petersen, and Gelfand with the tip design of McGurk to yield the predictable result of providing a tip on a trocar used to guide a catheter to a target location in a patient.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, and Gelfand as applied to claim 13 above, and further in view of U.S. Patent Publication 2018/0021507 to Tamrazi et al. (“Tamrazi”).
Regarding claim 14, Mogg, Petersen, and Gelfand teach the system of claim 13 as shown above, Mogg already teaching the jaw members as shown above and further teaching the jaws being biased in a closed configuration such as to form the tunnel therethrough (the jaws are biased closed via clips 59/60 and recesses 55/56, Fig. 4), but Mogg does not explicitly mention the material being flexible, although such a limitation could be considered inherent to one of ordinary skill.
In any case, Tamrazi has been cited to teach jaw members being made from a resiliently flexible material (abstract) being used to hold a flexible elongated medical device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a flexible material for the jaws of Mogg to yield the predictable result of providing a proper gripping characteristics for adequately holding a catheter without damaging the catheter.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, and Gelfand as applied to claim 1 above, and further in view of U.S. Patent No. 5,779,672 to Dormandy, Jr. (“Dormandy).
Regarding claim 17, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, but do not teach the balloon.
Dormandy teaches a catheter (26) including a balloon (12) having an internal passage to thread over an end of the catheter such that the balloon slides over the catheter to a desired location (Figs. 1 & 7). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the balloon into the catheter of Mogg, Petersen, and Gelfand to yield the predictable result of securing a catheter at a target location for optimal treatment.
Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Mogg, Petersen, and Gelfand as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2006/0282040 to Toman et al. (“Toman”).
Regarding claim 18, Mogg, Petersen, and Gelfand teach the system of claim 1 as shown above, but do not teach the pump.
Toman teaches a pump (Fig. 35), wherein the pump comprises two separate pumping members (328A/358A/360A & 328B/358B/360B) each connected to the medicament reservoir (24) and to respective catheters ([0176]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pump of Toman with the system of Mogg and Petersen to yield the predictable result of providing a pumping means to convey medicament through a catheter. The system of Mogg is used to clamp a catheter that conveys treatment fluid, Toman merely shows one example of how that treatment fluid is being conveyed.
Regarding claim 19, Mogg, Petersen, Gelfand, and Toman teach the system of claim 18 as shown above, Toman further teaching a power source (43) to power the pump and a control unit (118) to control a rate of flow of the medicament from the medicament reservoir to the two or more catheters ([0149]).
Regarding claim 20, Mogg, Petersen, Gelfand, and Toman teach the system of claim 19 as shown above, Toman further teaching the control unit is pre-programmed to deliver a pre-determined regimen of medicament over a period of time ([0162]).
Regarding claim 21, Mogg, Petersen, Gelfand, and Toman teach the system of claim 20 as shown above, Toman further teaching the pre-determined regimen includes different pre-programmed intervals ([0162]).
Regarding claim 22, Mogg, Petersen, Gelfand, and Toman teach the system of claim 21 as shown above, Toman further teaching a bolus interval wherein during the bolus interval, an increased amount of medicament is delivered to the patient compared to one or more of the other pre-programmed intervals ([0149] and [0155]).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2017/0021134 to Dambkowski et al. (“Dambkowski”) in view of Petersen, Gelfand, Toman, U.S. Patent Publication No. 2013/0263867 to Young, and Mogg.
Regarding claim 35, Dambkowski teaches a surgical kit comprising two or more catheters (61a & 60b, Fig. 19B) configured for implantation in a target tissue site of a patient, each catheter extending from a proximal end to a distal end and having a sidewall which defines an internal lumen (lumens of catheters 60a & 60b), an adhesive member ([0183], tape) configured to adhere to the skin of the patient around an exit wound, an open ring-shaped retaining member (40) comprising a substantially flat base (Fig. 19B), a guide surface (sides of 40) configured to receive a length of the two or more catheters and a plurality of retaining portions (940a-d) to retain the catheters against the guide surface, but does not teach the tunnelling trocar, the pump, the reservoir, the sheet, and particulars of the adhesive member.
Petersen teaches a tunnelling trocar (Fig. 2) configured for attachment to the proximal ends of the catheters, a nerve stimulating trocar comprising an elongate body (20) which is made from a material having a greater rigidity than the two or more catheters (column 2, lines 27-29), the nerve stimulating trocar configured to connect with the distal end of the catheters (Figs. 2-3), said distal end having one or more apertures (16) in the sidewall, and to advance the catheters through the tissue of the patient to the target tissue site and wherein the nerve stimulating trocar comprises a nerve stimulator configured to stimulate the one or more nerves adjacent to the target tissue site (column 3, lines 16-24). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dambkowski to incorporate the nerve stimulating trocar/catheter of Petersen to yield the predictable result of providing a means of inserting a catheter into the body to a target location. Dambkowski shows a kit for holding a catheter to treat the body and the catheter requires insertion into the body in order for the holder to function; Petersen shows an obvious art-recognized example of how said catheter may be inserted. Regarding the stimulation being configured to elicit a neural response, given that the electrode of Peterson imparts electrical current, as would be understood by a skilled artisan, the application of electrical current upon a nerve would elicit a neural response, even if it is brief or at least by adjacent nerves that are not cut.
In any case, Gelfand has been cited to teach the alternative use of electrodes for either stimulation or perforation ([0141]), the stimulation electrodes being capable of eliciting a neural response in one or more nerves. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted a stimulating electrode for the electrode of Petersen as taught by Gelfand to yield the predictable result of providing an art-recognized alternative electrode to suit the particular need or purpose depending on the treatment required by the caregiver.
Toman teaches a pump (Fig. 35) and a medicament reservoir (24). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pump and reservoir of Toman with the kit of Dambkowski and Petersen to yield the predictable result of providing a pumping means to convey medicament through a catheter. The kit of Dambkowski is used to hold a catheter that conveys treatment fluid, Toman merely shows one example of how that treatment fluid is being conveyed.
Young teaches a sheet (10) for application to the patient's skin around the surgical site, the sheet having an adhesive surface for adhering to the skin of the patient and a series of frangible regions for removal of parts of the sheet ([0013]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the sheet of Young with the kit of Dambkowski in order to cover the skin surrounding an exposed surgical field in order to maintain a sterile environment ([0002]) for when the catheter is inserted as is known in the art.
Although Dambkowski teaches an adhesive member as shown above, Dambkowski does not teach the adhesive member having an aperture.
Mogg teaches an adhesive member (7) having an aperture therein to allow the catheters to pass through the adhesive member. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the adhesive member of Dambkowski with the adhesive member of Mogg to yield the predictable result of attaching the base to the patient. Once combined, the open ring-shaped retaining member of Dambkowski would to be overlaid on the adhesive member.
Allowable Subject Matter
Claim 10 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 and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record to Mogg, Petersen, Spofford, and McGurk do not teach either alone or in combination: the proximal region of the nerve stimulating catheter being configured to extend along an outer surface of the two or more catheters and the intermediate region passing through the trocar receiving opening such that the distal region is housed within the internal lumen of the two or more catheters and the distal tip extends from the distal end of the two or more catheters in combination with a the intermediate region of the nerve stimulating trocar forming a bend such that a main axis of the proximal region is offset and substantially parallel to a main axis of the distal region as substantially claimed above.
Response to Arguments
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. As stated above, Examiner submits that the electrode of Petersen is capable of providing at least some level of nerve stimulation. In any case, Gelfand has been cited to teach the alternative use of electrodes for stimulation or cutting/perforation.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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