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 .
Election/Restrictions
Applicant’s election without traverse of group B (Graft/Drainage Tube claims 20-2158-60 and 63-67) in the reply filed on 7/28/26 is acknowledged. The applicant has present new claims 58-67.
Claims 61 and 62 (a catheter and balloon catheter) are further withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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) 20-21, 59-60, 63-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nunez et al. 2008/0033527.
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6. Regarding claim 20 and noting figures 1 and 9 Nunez et al. discloses a method comprising: obtaining data from a sensor (it is inherent that the sensor provides data because it senses parameters such as described in [0033; 0036]) positioned at a plurality of locations between on and/or within a medical tube [0035], wherein the medical tube comprises one or more sensors (see sensors 122 and [0035]) positioned within or upon said medical tube; storing the data in a memory device (300) located on or within the medical tube, and transferring the data from the memory to a location outside the tube or medical device (See [0061] which states “…The codes are transmitted through antennas 308 to radiofrequency identification reader 324 and the codes are decoded such that the signals can be read by and/or viewed on an integrated monitoring device (not shown), such as an integrated external computing system including a display screen.”).
7. Regarding claim 21 Nunez et al. discloses further comprising the step of analyzing said data (see [0036] which states “…By measuring pressures within endoprosthesis 100 and manipulating signals generated by sensors 122 corresponding to or representative of the pressure, characteristics of endoprosthesis 100 can be monitored and analyzed….”).
8. Regarding claim 59, see fig. 1 supra.
9. Regarding claim 60, see [0036].
10. Regarding claim 63, see fig. 1 graft 100 supra.
11. Regarding claims 64 and 66 see [0059] and system 300.
12. Regarding claim 67, see [0061] which discloses a unique code.
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 20-21, 58-60, 64-67 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,524,694 (hereafter ‘594) and 11,389,070 (‘070) in view of Nunez et al. 2008/0033527.
Although the claims at issue are not identical, they are not patentably distinct from each other. For example current claim 20 recites:
“20. obtaining data from a sensor positioned at a plurality of locations between on and/or within a medical tube, wherein the medical tube comprises one or more sensors positioned within or upon said medical tube; storing the data in a memory device located on or within the medical tube, and transferring the data from the memory to a location outside the tube or medical device.”
Pat. 694 claims 1-4 and 7 recites:
“1. A method for determining degradation of a tube, comprising the steps of a) providing to a body passageway of a subject a medical device, where the medical device comprises a medical tube and a plurality of sensors positioned within or upon said medical tube, and b) detecting a change in a sensor positioned within or upon said medical tube, and thus determining degradation of the tube.
2. The method according to claim 1 wherein said one or more sensors includes a sensor within the matrix of the medical tube.
3. The method according to claim 1 wherein said plurality of sensors includes a sensor within or upon said medical tube.
4. The method according to claim 1 wherein said plurality of sensors are selected from the group consisting of fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, liquid volume sensors, liquid flow sensors, chemistry sensors, metabolic sensors, accelerometers, mechanical stress sensors and temperature sensors.
7. The method according to claim 1 wherein said medical tube is a graft or drainage tube.”
However, pat. 694 does not recite the methods of storing data in a memory device located on or within the medical tube and transferring the data from the memory to a location outside the tube or medical device.
Nunez et al. disclose such features as mentioned supra in paragraphs 5-12. It would have been obvious to one having ordinary skill in the art to modify pat. ‘694 and provide the features as currently claimed because sensors are known to store and track parameters where the data can be analyzed via computer or other external means by the practitioner treating a patient in need.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. 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:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 August 21, 2026
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