DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on 2/25/26. As directed by the amendment: no claims have been amended, claims 1-11 and 20-24 have been cancelled, and no new claims have been added. Thus, claims 12-19 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 12-19) in the reply filed on 2/25/26 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under the appropriate statute(s) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. US 61666548, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 12-19 recite specific methodology that is not described relative to the structures which are disclosed in the parent application. Furthermore, specifics of the structures claimed are also lacking from the parent application.
As such, all claims currently do not receive the priority date associated with US 61666548, and instead receive the priority date of 6/29/2012.
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 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11730484 in view of Mukherjee (US 20120053614) for claim 12, and over claims 1-10, variously, of the ‘484 patent in view of Mukherjee, and further in view of Schneider et al. (US 20070149922), Callas et al. (US 20090118700), Haim et al. (US 6198963), and/or Purdy et al. (US 20110092955) for claims 13-19. See the rejections of claims 12-19 under 35 U.S.C. 103(a) below regarding the teachings of these references.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12, 13, and 16-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mukherjee (US 20120053614) in view of Schneider et al. (US 20070149922).
Regarding claim 12, Mukherjee discloses a method for occluding an injured blood vessel (par. 0050-0051; fig. 14-16), the method comprising: advancing a catheter (VD) and a sheath (IS) along a catheterization path while a tip 24 of the catheter dilates one or more blood vessels along the catheterization path (VD being a “vascular dilator” acting via tip 24; par. 0051 and fig. 14-16); advancing the catheter and/or retracting the sheath to cause a balloon 30 of the catheter to extend beyond a distal end portion of the sheath after simultaneously advancing the catheter and the sheath along the catheterization path (par. 0051; fig. 14-16); and inflating the balloon 30 to at least partially occlude the injured blood vessel (par. 0051; fig. 14-16), except for disclosing wherein, when the balloon is inflated, a pressure-relief valve operably coupled with the balloon is configured to open at a threshold pressure between (a) a relative pressure within the balloon necessary to occlude the injured blood vessel and (b) a relative pressure within the balloon that would burst or otherwise further injure the injured blood vessel. However, Schneider et al. teaches utilizing, in an inflatable balloon mechanism of a balloon catheter (see par. 0004 for applicability in general to various types of balloon catheters), a pressure relief valve (par. 0010-0016) that will open at a pre-selected threshold pressure that avoids negative outcomes like bursting the balloon (“over-inflation” par. 0010-0016). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mukherjee to utilize a pressure relief valve for the balloon to accomplish the claimed methodology, as taught by Schneider et al., for the purpose of preventing accidental over-inflation of the balloon during use (Schneider et al. par. 0010-0016).
Regarding claim 13, Mukherjee discloses determining a position of a proximity-sensor target of the catheter or the sheath (the proximity-sensor target being the inflatable member 30, par. 0051) using an extracorporeal proximity sensor (marker 44) after simultaneously advancing the catheter and the sheath along the catheterization path (par. 0051; marker 44 is pictured extracorporeally in fig. 14, indicating specifically the position of the balloon in proximity to the distal end 14 of the sheath).
Regarding claim 16, Mukherjee discloses determining the position of the proximity-sensor target includes moving the proximity sensor relative to a patient (insertion of the device, par. 0051, including marker 44) until the proximity sensor indicates an external location on the patient corresponding to the position of the proximity-sensor target (via marker 44 as positioned in fig. 14).
Regarding claim 17, Mukherjee discloses selecting an axial length of the catheter to be at least 100% of the length of the catheterization path (see fig. 14-16 which illustrate the catheter extending the entirety of the catheterization path, and beyond the catheterization path to outside the body), which encompasses the claimed range of from about 100% to about 150% of the length of the catheterization path.
Further regarding claim 17, it would additionally have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the axial length of the catheter to be within the claimed relative range of the catheterization path since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. 0037 of the specification which indicates that the length can be within this claimed range or other another suitable range).
Regarding claim 18, Mukherjee discloses using the sheath as an arterial line after advancing the catheter and/or retracting the sheath to cause the balloon of the catheter to extend beyond the distal end portion of the sheath (the device is placed in an artery, per par. 0051, and therefore acts as an arterial line throughout every step of the procedure as placed).
Claims 13 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mukherjee in view of Schneider et al., and further in view of Callas et al. (US 20090118700).
Regarding claim 13, in the alternative, and claim 14, Mukherjee discloses positioning the balloon upstream from a vascular injury location (see fig. 14 and 15; par. 0051) and utilizing conventional means for confirming relative positioning of device elements (par. 0051), without specifically teaching utilizing these conventional means to verify the location of the device as a whole relative to the vascular injury. Callas et al. further teaches specifically utilizing an extracorporeal proximity sensor in the form of angiographic, fluoroscopic, or other guidance systems actively to position the proximity sensor target in the form of the distal end of the device relative to a treatment location (par. 0040 and 0074). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the guidance methodology taught by Callas et al. to position the catheter of Mukherjee in view of Schneider et al. in order to provide sufficient structure and methodology to ensure and verify that the catheter system is properly placed as positioned in fig. 14 of Mukherjee.
Claims 15 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mukherjee in view of Schneider et al., and further in view of Haim et al. (US 6198963).
Regarding claim 15, Mukherjee in view of Schneider et al. teaches the method as claimed, except for the proximity-sensor target including a passive radiofrequency tag and determining the position of the proximity-sensor target includes energizing the tag using the proximity sensor. However, Haim et al. teaches utilizing a radiofrequency tag 28 as a proximity-sensor target which is energized by an external proximity sensor 32 (via RF transmitter 80; see fig. 8B) to determine the position of the proximity-sensor target (col. 14, ln. 5-21). Regarding claim 16, in the alternative to the interpretation of Mukherjee above, Haim et al. further teaches moving the proximity sensor 32 on the patient until it indicates an external location on the patient (moving the device to location 30 as described in col. 9, ln. 31-52; additionally, moving to additional points 30 as described in col. 13, ln. 1-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the sensor arrangement of Haim et al. according to the methodology as disclosed, corresponding to the steps recited in claims 15 and 16, in order to provide sufficient structure and methodology to ensure and verify that the catheter system is properly placed as positioned in fig. 14 of Mukherjee.
Claims 18 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mukherjee in view of Schneider et al., and further in view of Purdy et al. (US 20110092955).
Regarding claim 18, in the alternative, and claim 19, Mukherjee discloses the method as claimed, except for using the sheath as an arterial line, which includes measuring a blood pressure within the injured blood vessel via an annular space between the catheter and the sheath. However, Purdy et al. teaches utilizing a sheath as an arterial line to measure blood pressure (par. 0035, 0124). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mukherjee in view of Schneider et al. to measure blood pressure within an annular space defined between the catheter and the sheath, as taught by Purdy et al., for the purpose of providing sufficient safety to ensure safety of the artery during the procedure by monitoring blood pressure in the area.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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.
/NATHAN R PRICE/Primary Examiner, Art Unit 3783