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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,029,870 B2, hereinafter "the '870 patent". Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '870 patent encompass all of the limitations of the instant claim.
The following claims are rejected on the ground of nonstatutory double patenting as being unpatentable over the '870 patent:
Claim 2; unpatentable over claim 3 of the '870 patent.
Claim 3; unpatentable over claim 4 of the '870 patent.
Claim 4; unpatentable over claim 5 of the '870 patent.
Claim 5; unpatentable over claim 6 of the '870 patent.
Claim 6; unpatentable over claim 7 of the '870 patent.
Claim 7; unpatentable over claim 8 of the '870 patent.
Claim 11; unpatentable over claim 5 of the '870 patent.
Claim 12; unpatentable over claim 6 of the '870 patent.
Claim 13; unpatentable over claim 10 of the '870 patent.
Claim 14; unpatentable over claim 11 of the '870 patent.
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.
Claims 1-4, 10-11 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lobl (U.S. Pub. 2007/0255237, hereinafter "Lobl"). Regarding claim 1, Lobl discloses an implantable medical device for withdrawing cerebrospinal fluid (CSF) from a CSF-containing space of a subject and for infusing fluid into the subject, the device comprising:
a first inlet configured to be accessed by a needle of an aspiration device;
a first outlet;
a first fluid pathway extending from the first inlet to the first outlet;
a second inlet;
a second outlet;
a second fluid pathway extending from the second inlet to the second outlet; and one or more CSF catheters comprising a first lumen, a first distal opening in fluid communication with the first lumen, a second lumen and a second distal opening in fluid communication with the second lumen,
wherein the first lumen is in fluid communication with, or is configured to be placed in fluid communication with the first fluid pathway,
wherein the second lumen is in fluid communication with, or is configured to be placed in fluid communication with the second fluid pathway, wherein the first distal opening is configured to be placed in the CSF-containing space of the subject, and
wherein the first fluid pathway is free of a filter configured to prevent passage of a microbe (see annotated Figure 16 below).
PNG
media_image1.png
681
705
media_image1.png
Greyscale
[AltContent: arrow][AltContent: textbox (inlet)][AltContent: arrow][AltContent: textbox (outlet)][AltContent: arrow][AltContent: textbox (second fluid pathway)][AltContent: arrow][AltContent: textbox (inlet)][AltContent: arrow][AltContent: textbox (outlet)][AltContent: arrow][AltContent: textbox (first fluid pathway)][AltContent: textbox (second lumen)][AltContent: arrow][AltContent: textbox (first lumen)][AltContent: arrow]
Lobl, Annotated Fig. 16.
Regarding claim 2, Lobl discloses the implantable medical device wherein the second fluid pathway comprises a filter configured to allow passage of a therapeutic fluid and configured to prevent passage of a microbe (filter; see para. [0058]). Regarding claim 3, Lobl discloses the implantable medical device wherein the second distal opening is configured to be placed in the CSF-containing space (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claim 4, Lobl discloses the implantable medical device, comprising self-sealing septum, wherein the septum is positioned across the first inlet (self-sealing elastomeric septum covers the reservoir; see para. [0039]). Regarding claim 10, Lobl discloses the implantable medical device wherein the second distal opening is configured to be placed in the CSF-containing space (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claim 11, Lobl discloses the implantable medical device, comprising a self-sealing septum, wherein the septum is positioned across the first inlet (self-sealing elastomeric septum covers the reservoir; see para. [0039]). Regarding claim 14, Lobl discloses the implantable medical device wherein the second inlet is configured to be coupled to an accessory device catheter (dual lumen catheter 102; see Figures 15-16). Regarding claim 15, Lobl discloses the implantable medical device wherein the first and second inlets are configured to be positioned in proximity to a skull (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claim 16, Lobl discloses the implantable medical device wherein at least a portion of the device is configured to be positioned in or around a burr hole in the skull (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claim 17, Lobl discloses a method comprising:
implanting the device of claim 1, in the subject,
aspirating CSF from the subject through the first distal opening, the first lumen, and the first fluid pathway, and
infusing a therapeutic fluid to the subject through the second fluid pathway, the second lumen, and the second distal opening (one side of the port receiving fluid from another source and the other side used to withdraw fluid from the target tissue; see para. [0058]).
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.
Claims 5-9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lobl.
Regarding claims 5-6, Lobl discloses the implantable medical device except wherein the device comprises a top surface, and wherein the top surface comprises the first inlet, and wherein the device comprises a side surface, wherein the side surface comprises the second inlet. Instead, the top surface comprises the second inlet, and the side surface comprises the first inlet (Figures 15 and 16).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the top surface with the first inlet and the side surface with the second inlet since rearranging parts requires routine skill in the art. Furthermore, the device would perform equally well with the aspiration in the second lumen and infusion in the first lumen. Regarding claim 7, Lobl discloses the implantable medical device wherein the second inlet is configured to be coupled to an accessory device catheter (dual lumen catheter, 102: Figures 15-16). Regarding claim 8, Lobl discloses the implantable medical device wherein the first and second inlets are configured to be positioned in proximity to a skull (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claim 9, Lobl discloses the implantable medical device wherein at least a portion of the device is configured to be positioned in or around a burr hole in a skull (see para. [0074], disclosing that drugs can be delivered to the brain through a hole in the skull using a bone needle; and see cerebro-spinal fluid in para. [0031]). Regarding claims 12-13, Lobl discloses the implantable medical device except wherein the device comprises a top surface, and wherein the top surface comprises the first inlet, and wherein the device comprises a side surface, wherein the side surface comprises the second inlet. Instead, the top surface comprises the second inlet, and the side surface comprises the first inlet (Figures 15 and 16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the top surface with the first inlet and the side surface with the second inlet since rearranging parts requires routine skill in the art. Furthermore, the device would perform equally well with aspiration through the second fluid pathway to the second lumen and infusion through the first fluid pathway to the first lumen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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, Chelsea Stinson can be reached on (571) 270-1744. 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.
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/13/2026
Prosecution Insights