DETAILED ACTION
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 2-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 17 of U.S. Patent No. 9,764,122 in view of Greengrass et al. (US 5,976,110), and further in view of McKay (US 2010/0228097). It is further noted that the restriction requirement, mailed July 13, 2016 in application 14/341,256, required an election of species. The instant method claims are considered generic to all species which were set forth in the restriction and therefore the double patenting rejection is considered proper.
Regarding claim 2, the patent discloses method of delivering at least one drug depot to treat pain associated with a sciatic nerve of a patient, the method comprising: inserting a distal end of a drug delivery device through skin of the patient to a target site (Col. 25, lines 55-62), wherein the drug delivery device comprises: a cannula having an open proximal end and an open distal end and a lumen extending from the proximal end to the distal end (Col. 25, lines 57-62); a drug cartridge defining a depot channel which is loaded with said at least one drug depot (Col. 26, lines 1-12), wherein the drug cartridge includes at least a first occluding device (Col. 26, lines 3-5)configured to at least partially occlude the depot channel at a first occluding position such that the at least one drug depot cannot pass through the depot channel at the first occluding position without force, greater than that of gravity, applied to the drug depot sufficient to deflect the first occluding device an amount permitting passage of the drug depot past the first occluding device (Col. 26, lines 1-12); a housing having a top end, a bottom end, and an interior cavity, wherein the bottom end of the housing is configured to couple to the proximal end of a cannula (Col. 25, lines 63-67 and Col. 26, lines 13-15) and wherein the interior cavity of the housing is configured to receive the drug cartridge (the cartridge is aligned with the housing channel as per claim 1; see also claim 7 which discloses the housing receiving the cartridge therein); and a plunger having a push rod slidably receivable in the interior cavity of the housing and the depot channel of the drug cartridge and the lumen of the cannula, wherein the push rod comprises a push rod end configured to contact the at least one drug depot disposed in the depot channel of the drug cartridge and, upon application of force, expel the at least one drug depot through the first occluding device and into the cannula (Col. 26, lines 15-21; the push rod must extend within both the housing channel and cartridge depot channel to deploy the medicament through the cannula); inserting the push rod of the plunger into the interior cavity of the housing and into the depot channel of the drug cartridge; applying force to expel the at least one drug depot through the first occluding device and into the cannula; and advancing the push rod end through the lumen and out of the open distal end of the cannula to deploy the at least one drug depot to the target site within the patient (Col. 26, lines 15-21, the plunger moves the depot through the housing channel and cartridge depot channel to deliver it through the cannula). The patent fails to explicitly disclose the treatment of pain associated with a sciatic nerve of a patient, the location being a lumbar epidural space, and the cannula device being a Tuohy needle with a bevel or taper at its distal end.
Greengrass et al. (henceforth Greengrass) teaches a Tuohy needle comprising a beveled tip (12; Col. 3, lines 23-28) which is utilized to treat pain associated with the sciatic nerve via injection into the lumbar epidural space (Col. 4, lines 23-33 disclose the location as a sciatic nerve plexus or lumbar nerve plexus and Col. 4, line 57-Col. 5, line 4 disclose drug delivery at the target site; the device is used during surgery to achieve a peripheral nerve blockade and this will prevent pain associated with a sciatic nerve of a patient, however Greengrass fails to explicitly disclose the procedure as a response to sciatic nerve pain), and further, the device is attachable at a proximal end (e.g., at hub “H”, Figure 1) to additional devices.
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the device of the patent for treating sciatic nerve pain via entry into a lumbar epidural space via a Tuohy needle, as Greengrass teaches that such an instrument is known for use in such nerve block procedures for delivering a drug to the claimed site during a procedure.
As above, the patent and Greengrass are silent regarding the use of the device of Greengrass as a treatment response to sciatic nerve pain. However, McKay teaches (Figure 2B) using a needle or cannula to place a drug depot at a lumbar epidural space for relief of sciatic nerve pain (¶¶ [0028], [0048], [0129]; the cited paragraphs disclose placement of a drug depot using various means such as a Tuohy needle into the lumbar epidural space for treatment of sciatic nerve pain).
It would have been obvious to one of ordinary skill in the art at the time of filing to perform the instant method using the device of the patent to treat sciatic nerve pain since McKay teaches that utilizing such a device to place a drug depot at the claimed site is known for treating pain associated with the sciatic nerve without requiring invasive surgery (e.g., ¶ [0012]).
Regarding claim 3, the patent further discloses coupling the bottom end of the housing to the proximal end of the Tuohy needle (Col. 26, lines 13-15 disclose coupling to the cannula which would be modified into the Tuohy needle of Greengrass in the cited combination).
Regarding claim 4, the patent fails to explicitly disclose the depot as a pellet, however, McKay teaches the use of a depot in the form of a pellet for application to the target site for longer term effects (¶ [0051]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of using the patent device to include the step of depositing a pellet, as taught by McKay, for the purpose of delivering treatment over a period of time as taught by McKay.
Regarding claims 5 and 6, the patent further discloses the drug depot as an analgesic agent (clonidine, claim 17).
Regarding claim 7, McKay further teaches wherein the at least one drug depot comprises a biodegradable sustained release biopolymer configured to provide sustained release of the clonidine (¶ [0094] discloses that the analgesic agent may further comprise biodegradable biopolymers for sustained release of the drug after implantation). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of using the patent device to include the use of a biodegradable polymer as part of the drug depot so as to allow for sustained release of the analgesic at the target site over a desired time period as taught by McKay.
Regarding claim 8, McKay further teaches the method of use for the treatment of sciatica (¶¶ [0043] and [0059]).
Regarding claim 9, the patent fails to explicitly teach the use of three drug depots, however, McKay further teaches the deposition of three drug depots at the target site (e.g., 28, Figure 2B; ¶ [0152]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of use of the patent device to include depositing three depots at the target site to ensure full effect on the pain generation site as taught by McKay.
Claims 10-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 9,764,122 in view of McKay.
Regarding claim 10, patent claim 1 discloses a device for delivering at least one drug depot to a target site comprising: a cannula having a proximal end and an open distal end (Col. 25, lines 57-62); a drug cartridge defining a depot channel which is loaded with said at least one drug depot (Col. 26, lines 1-3), a housing having a top end, a bottom end, and an interior cavity, wherein the bottom end of the housing is configured to couple to the proximal end of the cannula and wherein the interior cavity of the housing is configured to receive the drug cartridge (Col. 25, line 63-Col. 26, line 3 disclose the housing and the cartridge channel aligned with the housing channel; see also claim 6 which discloses that the cartridge can be viewed from the housing window thereby locating the cartridge within the housing assembly and claim 7 which discloses the housing receiving the cartridge); and a plunger comprising a push rod having a distal end configured to contact the at least one drug depot disposed in the depot channel of the drug cartridge and, upon application of force, expel the at least one drug depot out of the drug cartridge (Col. 26, lines 15-21); inserting the distal end of the push rod of the plunger into the interior cavity of the housing and into the depot channel of the drug cartridge; applying force to expel the at least one drug depot out of the drug cartridge and into the cannula; and continuing to advance the distal end of the push rod of the plunger through the cannula and out of the open distal end of the cannula to deploy the at least one drug depot to the target site (Col. 26, lines 15-21 disclose using the push rod of the plunger to abut the drug depot therein and move it though the cartridge and housing for delivery through the cannula). The patent fails to disclose the method of use of the device for treating sciatic nerve pain and the target site being an epidural space of a spine of the patient.
McKay teaches (Figure 2B) using a needle or cannula to place a drug depot at a lumbar epidural space for relief of sciatic nerve pain (¶¶ [0028], [0048], [0129]; the cited paragraphs disclose placement of a drug depot using various means such as a Tuohy needle into the lumbar epidural space for treatment of sciatic nerve pain).
It would have been obvious to one of ordinary skill in the art at the time of filing to perform the instant method using the device of the patent to treat sciatic nerve pain since McKay teaches that utilizing such a device to place a drug depot at the claimed site is known for treating pain associated with the sciatic nerve without requiring invasive surgery (e.g., ¶ [0012]).
Regarding claim 11, the patent further discloses coupling the bottom end of the housing to the proximal end of the cannula (Col. 26, lines 13-15 disclose coupling to the cannula).
Regarding claim 12, the patent fails to explicitly disclose the depot as a pellet, however, McKay teaches the use of a depot in the form of a pellet for application to the target site for longer term effects (¶ [0051]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of using the patent device to include the step of depositing a pellet, as taught by McKay, for the purpose of delivering treatment over a period of time as taught by McKay.
Regarding claims 13 and 14, the patent further discloses the drug depot as an analgesic agent (clonidine, claim 17).
Regarding claim 15, McKay further teaches wherein the at least one drug depot comprises a biodegradable sustained release biopolymer configured to provide sustained release of the clonidine (¶ [0094] discloses that the analgesic agent may further comprise biodegradable biopolymers for sustained release of the drug after implantation). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of using the patent device to include the use of a biodegradable polymer as part of the drug depot so as to allow for sustained release of the analgesic at the target site over a desired time period as taught by McKay.
Regarding claim 16, McKay further teaches the method of use for the treatment of sciatica (¶¶ [0043] and [0059]).
Regarding claim 17, the patent fails to explicitly teach the use of three drug depots, however, McKay further teaches the deposition of three drug depots at the target site (e.g., 28, Figure 2B; ¶ [0152]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of use of the patent device to include depositing three depots at the target site to ensure full effect on the pain generation site as taught by McKay.
Regarding claims 18 and 19, patent claim 1 discloses a device for delivering at least one drug depot to a target site comprising: a cannula having a proximal end and an open distal end (Col. 25, lines 57-62); a drug cartridge defining a depot channel which is loaded with said at least one drug depot (Col. 26, lines 1-3), a housing having a top end, a bottom end, and an interior cavity, wherein the bottom end of the housing is configured to couple to the proximal end of the cannula and wherein the interior cavity of the housing is configured to receive the drug cartridge (Col. 25, line 63-Col. 26, line 3 disclose the housing and the cartridge channel aligned with the housing channel; see also claim 7 which discloses the housing receiving the cartridge as per claim 19); and a plunger comprising a push rod having a distal end configured to contact the at least one drug depot disposed in the depot channel of the drug cartridge and, upon application of force, expel the at least one drug depot out of the drug cartridge (Col. 26, lines 15-21); inserting the distal end of the push rod of the plunger into the interior cavity of the housing and into the depot channel of the drug cartridge; applying force to expel the at least one drug depot out of the drug cartridge and into the cannula; and continuing to advance the distal end of the push rod of the plunger through the cannula and out of the open distal end of the cannula to deploy the at least one drug depot to the target site (Col. 26, lines 15-21 disclose using the push rod of the plunger to abut the drug depot therein and move it though the cartridge and housing for delivery through the cannula). The patent fails to disclose the method of use of the device for treating sciatic nerve pain and the target site being an adjacent the sciatic nerve of the patient.
McKay teaches (Figure 2B) using a needle or cannula to place a drug depot at a lumbar epidural space for relief of sciatic nerve pain (¶¶ [0028], [0048], [0129]; the cited paragraphs disclose placement of a drug depot using various means such as a Tuohy needle into the lumbar epidural space for treatment of sciatic nerve pain; see also ¶ [0027] which discloses placing the depot at or near the target site such as a nerve; ¶¶ [0054] and [0130] also disclose placing the depot at a nerve root; see also ¶ [0148] which discloses determining a herniated disc induced pain via nerve root examination for diagnosing pain of the sciatic nerve).
It would have been obvious to one of ordinary skill in the art at the time of filing to perform the instant method using the device of the patent to treat sciatic nerve pain at the sciatic nerve root since McKay teaches that utilizing such a device to place a drug depot at the claimed site is known for treating pain associated with the sciatic nerve without requiring invasive surgery (e.g., ¶ [0012]).
Regarding claim 20, the patent further discloses coupling the bottom end of the housing to the proximal end of the cannula (Claim 1; Col. 26, lines 13-15 disclose coupling to the cannula).
Regarding claim 21, the patent fails to explicitly disclose the depot as a pellet, however, McKay teaches the use of a depot in the form of a pellet for application to the target site for longer term effects (¶ [0051]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of using the patent device to include the step of depositing a pellet, as taught by McKay, for the purpose of delivering treatment over a period of time as taught by McKay.
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) 2-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simonton et al. (US 2012/0053561) in view of Loos (US 2001/0031940).
Regarding claim 2, Simonton et al. (henceforth Simonton) discloses a method of delivering at least one drug depot to treat pain associated with a sciatic nerve of a patient (¶ [0129]), the method comprising: inserting a distal end of a drug delivery device through skin of the patient to a target site within a lumbar epidural space (¶ [0071] discloses that the diameter of the needle is based upon available epidural space in the lumbar region), wherein the drug delivery device comprises: a Tuohy needle (¶ [0069] discloses using a Tuohy needle) having an open proximal end (attached at 144, Figure 6) and an open distal end (beveled distal tip of 142) and a lumen extending from the proximal end to the distal end (within 142), wherein the distal end of the Tuohy needle is tapered or beveled (¶ [0069]); a drug cartridge (98, Figure 4) defining a depot channel (97; ¶ [0051]) which is loaded with said at least one drug depot (91-93, Figure 4; ¶ [0049]), a housing (103; Figure 4) having a top end, a bottom end, and an interior cavity (Figures 1-4), wherein the bottom end of the housing is configured to couple to the proximal end of the Tuohy needle (Figure 6) and wherein the interior cavity of the housing is configured to receive the drug cartridge (see e.g., Figures 4-5); and a plunger (12; Figure 1) having a push rod (13) slidably receivable in the interior cavity of the housing and the depot channel of the drug cartridge and the lumen of the Tuohy needle (¶ [0037]), wherein the push rod comprises a push rod end (terminal distal end of shaft) configured to contact the at least one drug depot disposed in the depot channel of the drug cartridge and, upon application of force, expel the at least one drug depot through the first occluding device and into the Tuohy needle (¶¶ [0037] and [0045]); inserting the push rod of the plunger into the interior cavity of the housing and into the depot channel of the drug cartridge (¶ [0045]; applying force to expel the at least one drug depot through the first occluding device and into the Tuohy needle; and advancing the push rod end through the lumen and out of the open distal end of the Tuohy needle to deploy the at least one drug depot to the target site within the lumbar epidural space (¶ [0045] discloses moving the depot through the cartridge and housing and through the needle). Simonton fails to explicitly disclose the first occluding device.
Loos teaches (Figure 1) a device for administering implants which comprises first and second occluding devices (6, 7) for retaining a depot (5) within the device until a push rod (4) is moved against the depot with sufficient force to pass it through the device and into the cannula for delivery (¶¶ [0017]-[0018]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the drug cartridge of Simonton to comprise the occluding device of Loos to provide a means of securely retaining the drug depots within the cartridge until they are to be delivered by means of a piston rod as taught by Loos.
Regarding claim 3, Simonton further discloses coupling the bottom end of the housing to the proximal end of the Tuohy needle (Figure 4, ¶ [0049] discloses coupling the housing second end to the needle or cannula via a variety of means such as a luer fitting 106).
Regarding claim 4, Simonton further discloses wherein the drug depot is in the form of a drug pellet (91-93; ¶ [0094]).
Regarding claims 5-6, Simonton further discloses wherein the drug depot comprises an analgesic agent (¶¶ [0088] and [0090] disclose the use of clonidine, an analgesic, for the depot).
Regarding claim 7, Simonton further discloses wherein the at least one drug depot comprises a biodegradable sustained release polymer configured to provide sustained release of the clonidine (¶ [0091] discloses a biodegradable polymer for sustained release).
Regarding claim 8, Simonton further discloses the method of treatment for sciatica (¶ [0129]).
Regarding claim 9, Simonton further discloses wherein the at least one depot consists of three drug depots (¶ [0049] discloses three depots 91-93).
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) 10-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simonton.
Regarding claims 10, 18, and 19, Simonton discloses a method of delivering at least one drug depot to treat pain associated with a sciatic nerve of a patient (¶ [0129]), the method comprising: inserting a distal end of a drug delivery device (needle 142, Figure 6) through skin of the patient to a target site within an epidural space (¶ [0071]; see also ¶ [0133] which discloses depositing the depot adjacent a nerve root for targeted delivery; this coupled with the disclosure of treating sciatic pain provides anticipation of depositing the depot adjacent the sciatic nerve to treat sciatic nerve pain as per claim 18) of a spine of the patient, wherein the drug delivery device comprises: a cannula (142) having a proximal end and an open distal end (Figure 6); a drug cartridge (98, Figure 4) defining a depot channel (97) which is loaded with said at least one drug depot (91-93, Figure 4; ¶ [0049]), a housing having a top end, a bottom end, and an interior cavity, wherein the bottom end of the housing is configured to couple to the proximal end of the cannula (142, Figure 6; ¶ [0060]) and wherein the interior cavity of the housing is configured to receive the drug cartridge (Figure 4, the cartridge slides into the housing; also for claim 19); and a plunger (12) comprising a push rod (13) having a distal end (tip of 12) configured to contact the at least one drug depot disposed in the depot channel of the drug cartridge and, upon application of force, expel the at least one drug depot out of the drug cartridge (¶¶ [0037] and [0045]); inserting the distal end of the push rod of the plunger into the interior cavity of the housing and into the depot channel of the drug cartridge (¶¶ [0037] and [0045]); applying force to expel the at least one drug depot out of the drug cartridge and into the cannula; and continuing to advance the distal end of the push rod of the plunger through the cannula and out of the open distal end of the cannula to deploy the at least one drug depot to the target site within the epidural space or adjacent the sciatic nerve (¶¶ [0037] and [0045]).
Regarding claims 11 and 20, Simonton further discloses coupling the bottom end of the housing to the proximal end of the Tuohy needle (Figure 4, ¶ [0049] discloses coupling the housing second end to the needle or cannula via a variety of means such as a luer fitting 106).
Regarding claims 12 and 21, Simonton further discloses wherein the drug depot is in the form of a drug pellet (91-93; ¶ [0094]).
Regarding claims 13-14, Simonton further discloses wherein the drug depot comprises an analgesic agent (¶¶ [0088] and [0090] disclose the use of clonidine, an analgesic, for the depot).
Regarding claim 15, Simonton further discloses wherein the at least one drug depot comprises a biodegradable sustained release polymer configured to provide sustained release of the clonidine (¶ [0091] discloses a biodegradable polymer for sustained release).
Regarding claim 16, Simonton further discloses the method of treatment for sciatica (¶ [0129]).
Regarding claim 17, Simonton further discloses wherein the at least one depot consists of three drug depots (¶ [0049] discloses three depots 91-93).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights