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 .
Detailed Action
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (USP 6,482,309) in view of Scholz et al. (US PG Pub. 2003/0194447A1).
Green et al. discloses an invention relating to compositions and devices for transferring anti-infective activity to medical devices through electrolytic generation of elemental iodine, allowing for its transfer to the polymer base of urinary and venous catheters, wound drain tubes, and other medical devices, conferring to such devices prophylactic and therapeutic treatment of implant-linked infections, see column 1, second paragraph. The reference teaches that the device may comprise a medical device such as a catheter, drain tube, or implant. Alternatively, the device may comprise an insert member configured to be slidably insertable into a lumen of a medical device or insertable around the medical device, to transfer the anti-infective oxidant from the device into a wall of the medical device defining the medical device lumen, (see column 5, lines 21-27 and lines 58-62). The reference teaches that an alternative insert member which embodies features of the invention, has the anode member embedded within a polymeric wall of the insert member. The polymeric wall, formed of a polymeric material such as silicone, is impregnated with the oxidant generating formulation, such as potassium iodide. In such embodiment, the insert member is a solid-walled member, however, in alternative embodiments, the insert member may be hollow, so that the polymeric wall having the oxidant generating formulation dispersed therein defines at least in part a lumen or chamber. The cathode member is also included in fabrication of the device running parallel to the anodic lead wire. Arrows lateral to the long axis of the device illustrate the egress of nascent iodine from the polymer base as it is formed and diffuses outward from the polymeric wall and into surrounding body fluids and tissues in contact with the device, (see column 10, lines 7-21). Use of citric acid (buffering agent) and sodium iodate (oxidizing agent) is taught in table 1 of column 15.
Green et al. do not teach the amount of available iodine and povidone iodine.
Scholz et al. teaches antiseptic compositions and methods, see title. Scholz et al. teaches that the composition comprises antimicrobial iodine with an available iodine concentration of at least about 0.25 wt. % and water, see abstract. The reference teaches povidone-iodine that generates elemental iodine with an available iodine no greater than 1.0wt. %, see [0009]. Scholz teaches iodophore including polyvinylpyrrolidone (povidone) to be in an amount greater than 5 wt. %, see [0013].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized available iodine from povidone-iodine concentration of at least about 0.25% and manipulate this amount for optimum antibacterial effect by performing experimental manipulations. One of ordinary skill would have been motivated to do so because substitution of one source of elemental iodine with another would have provided predictable results of obtaining an antimicrobial solution sued in a medical device.
Nonstatutory double patenting rejection
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-16 of (U.S. Patent No. 12,171,235).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite an antimicrobial catheter system for a patient, the system comprising: a catheter device having a lumen and an inflatable balloon defined by a wall formed of an elastomeric polymer that is liquid-impermeable and gas-permeable, the inflatable balloon being configured for at least partial placement into the patient; and an antimicrobial solution that is introducible in a stable state into the lumen to inflate the balloon of the catheter device, the antimicrobial solution comprising 0.01% to 1% iodine by weight and 85% to 98% water by weight; whereupon introduction of the antimicrobial solution into the balloon is configured to provide a vapor pressure differential to the antimicrobial solution to generate free elemental iodine such that the elemental iodine diffuses through the wall of the balloon to form an antimicrobial region proximate an outer surface of the wall of the chamber. The patented claims recite an antimicrobial catheter system for a patient, the system comprising: a catheter device having a lumen and an inflatable balloon defined by a wall formed of an elastomeric polymer that is liquid-impermeable and gas-permeable, the inflatable balloon being configured for at least partial placement into the patient; and an antimicrobial solution that is introducible in a stable state into the lumen to inflate the balloon of the catheter device, the antimicrobial solution comprising 0.01% to 1% iodine by weight and 85% to 98% water by weight; whereupon introduction of the antimicrobial solution into the balloon provides a vapor pressure differential to the antimicrobial solution to generate free elemental iodine such that the elemental iodine diffuses through the wall of the balloon to form an antimicrobial region proximate an outer surface of the wall of the chamber. The patented antimicrobial catheter reads on the claimed antimicrobial catheter system.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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, Sahana S. Kaup can be reached at 571-272-6897. 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.
/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
Prosecution Insights