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 Invention I in the reply filed on 04/24/2023 is acknowledged. In Applicant’s reply, Applicant failed to elect a species. However during a telephone conversation with Richard Dyer on 05/30/2023, Applicant elected Invention I and Species A, which is drawn to an endoscope/tissue closure system having a tissue engaging portion as illustrated in Fig. 1B, as applied to claims 1 and 10, without traverse. Applicant’s telephone election is acknowledged.
Response to Amendment
The amendment filed 08/13/2025 has been entered. Claims 1-4, 6-13, and 15-17 are pending. Claims 5, 14, and 18-20 have been canceled. Claims 2-4, 6-9, 11-13, and 15-17 have been withdrawn. Claims 1 and 10 have been amended. Claims 1 and 10 are examined below.
Response to Arguments
The arguments with respect to the pending claims have been considered but are moot because Applicant has amended independent claim 1 and independent claim 10, with amendments that change the scope of the claims. As such, the claims require a new ground of rejection, which is presented below.
Please see the rejections under 35 U.S.C §103 below for further explanation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the shaft" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the flexible steerable shaft.” Appropriate correction is required.
Claim 10 recites the term “a proximal end” in lines 24 and 26. However, claim 10 line 3 also recites the term ‘a proximal end.’ Therefore it is unclear whether the limitations in lines 24 and 26 are introducing new proximal ends of the first control element and the second control element, respectively, or simply referencing the proximal end of the flexible tube previously introduced in line 3. It is suggested to amend the limitations in line 24 and 26 to state “the proximal end.” Alternatively, Applicant could amend lines 24-26 to state, “wherein the first control element having of the tissue acquisition assembly, and a second control element having of the tissue closure assembly.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US2013/0090526) hereinafter Suzuki in view of Gilreath et al. (US2005/0080342) hereinafter Gilreath.
Regarding Claim 1, Suzuki discloses a single-use integrated tissue closure system, comprising:
an endoscope (Figs. 221-231 tissue centesis system 1001) having a flexible steerable shaft (Figs. 221-231 sheath portion 1007, [0439-0442] “The sheath portion 1007 has an endoscopic lumen 1010 into which the endoscope 1009 can be slidably inserted and two needle lumens 1011 a and 1011 b into which the inner sheaths 1004 a and 1004 b can be slidably inserted, and has the flexibility so as to be capable of following up bend of the endoscope 1009.”) with a proximal end (see annotated Fig. 221), a distal end (see annotated Fig. 221), and a first lumen (see annotated Fig. 225) and a second lumen (see annotated Fig. 225) extending therethrough, between the proximal end (see annotated Fig. 221) and the distal end (see annotated Fig. 221), and a control handle (see annotated Fig. 221) mounted on the proximal end (see annotated Fig. 221) of the shaft (Figs. 221-231 sheath portion 1007) and including a first actuator (Fig. 221 knobs on endoscope 1009) and a second actuator (Figs. 141, 221 needle sliders 1043a/b);
a first control element (Sheath of endoscope 1009) disposed within the first lumen (see annotated Fig. 225) and having a proximal end coupled to the first actuator (Fig. 221 knobs on endoscope 1009);
a second control element (Figs. 221-231 needle main body 1200) disposed within the second lumen (see annotated Fig. 225) and having a proximal end coupled to the second actuator (Figs. 141, 221 needle sliders 1043a/b); and
a tissue engaging portion (Figs. 221-231 treatment lumen 1013 and endoscope 1009 and needle 1199 via needle main body 1200) integral with and formed as a part of the distal end (see annotated Fig. 221) of the flexible steerable shaft (Figs. 221-231 sheath portion 1007) of the endoscope (Figs. 221-231 tissue centesis system 1001), the tissue engaging portion (Figs. 221-231 endoscope 1009 and needle 1199 via needle main body 1200) comprising a tissue acquisition assembly (Figs. 221-231 endoscope 1009) and a tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200), the tissue acquisition assembly (Figs. 221-231 endoscope 1009) controllable via the first actuator (Fig. 221 knobs on endoscope 1009) and the first control element (Sheath of endoscope 1009), the tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200) controllable via the second actuator (Figs. 141, 221 needle sliders 1043a/b) and the second control element (Figs. 221-231 needle main body 1200);
wherein the tissue engaging portion (Figs. 221-231 treatment lumen 1013 and endoscope 1009 and needle 1199 via needle main body 1200) comprises a tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190 within lumen 1013), the tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190)comprising one or more actuatable tissue-engaging elements (Figs. 221-231 suture thread 1068 and grasping portion 1190 via grasping forceps 1189 or loop opening 1098)configured for engaging first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) disposed adjacent an opening (Figs. 221-231 space between tissue 1097a and 1097b) in a target tissue (Figs. 221-231 tissue 1097a and 1097b);
wherein the tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200) is configured to pierce (Fig. 227) the target tissue (Figs. 221-231 tissue 1097a and 1097b), and to hold (Fig. 227) the first and second target tissue portions tissue (Figs. 221-231 tissue 1097a and 1097b) together to close the opening in the target tissue (Figs. 221-231 tissue 1097a and 1097b) ; and
wherein the tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190 within the lumen 1013) comprises a distal tip portion (Figs. 221-231 lumen 1013) having a suction channel disposed therethrough ([col. 1079-1090] “…the side opening 1013 is positioned above the suture tissues 1097 a and 1097 b, and thereafter suction is carried out by the endoscope 1009., the suction channel in fluid communication with a suction source ([0732] “In place of using the suction function of the endoscope 1009, the suction tube 1200 is connected to the suction source (not shown) and the suture tissues 1097 a and 1097 b are sucked from the side opening 1013.”), the distal tip portion (Figs. 221-231 lumen 1013) made from a flexible material ([0444-0445]) “The treatment lumen 1013 is surrounded by the outer wall 1015 b.The sheath portion 1007 is formed of a plastic material which is relatively soft and superior in the transparency such as polyurethane, polyvinyl chloride, polyurethane-based elastomer, polystyrene-based elastomer or polyolefin-based elastomer, and the outer side of the sheath portion 1007 can be observed by the endoscope 1009 inserted into the endoscopic lumen 1010 through the sheath portion 1007.”) for pressing against the target tissue (Figs. 221-231 tissue 1097a and 1097b), wherein the distal tip portion (Figs. 221-231 lumen 1013) is engageable with the target tissue (Figs. 221-231 tissue 1097a and 1097b) such that the suction channel overlies a tissue opening (Figs. 221-231 space between tissue 1097a and 1097b) to engage the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b), wherein suction applied via the suction channel causes the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) to be drawn into the suction channel to press the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) together ([0642-0645] “…the suture tissues 1097 a and 1097 b are pulled into the treatment lumen 1012 from the side opening 1013 by the suction function or the like provided to the endoscope 1009.”).
PNG
media_image1.png
1383
1464
media_image1.png
Greyscale
While Suzuki discloses the tissue closure system disclosed above, Suzuki fails to teach that the tissue closure system is a single-use integrated tissue closure system.
However Gilreath, in the same field of endeavor, teaches a device and system for in-vivo procedures that is a single-use integrated tissue closure system (Gilreath – [0006] “ The device and system, according to an embodiment of the invention, may be a single-use device or system or may comprise single-use components, essentially eliminating the need for sterilization in between uses, ….”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the tissue closure system as taught by Suzuki with the teaching of a single use device as taught by Gilreath for the benefit of “essentially eliminating the need for sterilization in between uses” [Gilreath – [0006].
Regarding Claim 10, Suzuki discloses a single-use integrated endoscope (Figs. 221-231 tissue centesis system 1001), comprising:
a handle (see annotated Fig. 221) including first (Fig. 221 knobs on endoscope 1009) and second actuators (Figs. 141, 221 needle sliders 1043a/b);
a flexible tube (Figs. 221-231 sheath portion 1007, [0439-0442] “The sheath portion 1007 has an endoscopic lumen 1010 into which the endoscope 1009 can be slidably inserted and two needle lumens 1011 a and 1011 b into which the inner sheaths 1004 a and 1004 b can be slidably inserted, and has the flexibility so as to be capable of following up bend of the endoscope 1009.”) having an articulable, steerable distal end (see annotated Fig. 221), and a proximal end (see annotated Fig. 221), the handle (see annotated Fig. 221) being mounted on the proximal end (see annotated Fig. 221) of the flexible tube (Figs. 221-231 sheath portion 1007); and
a tissue engaging portion (Figs. 221-231 treatment lumen 1013 and endoscope 1009 and needle 1199 via needle main body 1200) integral to and formed as a part of the articulable, steerable distal end (see annotated Fig. 221) of the flexible tube (Figs. 221-231 sheath portion 1007), the tissue engaging portion (Figs. 221-231 treatment lumen 1013 and endoscope 1009 and needle 1199 via needle main body 1200) comprising a tissue acquisition assembly (Figs. 221-231 endoscope 1009) and a tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200);
wherein the tissue engaging portion (Figs. 221-231 treatment lumen 1013 and endoscope 1009 and needle 1199 via needle main body 1200) comprises a tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190 within lumen 1013), the tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190)comprising one or more actuatable tissue-engaging elements (Figs. 221-231 suture thread 1068 and grasping portion 1190 via grasping forceps 1189 or loop opening 1098)configured for engaging first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) disposed adjacent an opening (Figs. 221-231 space between tissue 1097a and 1097b) in a target tissue (Figs. 221-231 tissue 1097a and 1097b);
wherein the tissue grasping portion (Figs. 221-231 suture thread 1068 and grasping portion 1190 within the lumen 1013) comprises a distal tip portion (Figs. 221-231 lumen 1013) having a suction channel disposed therethrough ([col. 1079-1090] “…the side opening 1013 is positioned above the suture tissues 1097 a and 1097 b, and thereafter suction is carried out by the endoscope 1009., the suction channel in fluid communication with a suction source ([0732] “In place of using the suction function of the endoscope 1009, the suction tube 1200 is connected to the suction source (not shown) and the suture tissues 1097 a and 1097 b are sucked from the side opening 1013.”), the distal tip portion (Figs. 221-231 lumen 1013) made from a flexible material ([0444-0445]) “The treatment lumen 1013 is surrounded by the outer wall 1015 b.The sheath portion 1007 is formed of a plastic material which is relatively soft and superior in the transparency such as polyurethane, polyvinyl chloride, polyurethane-based elastomer, polystyrene-based elastomer or polyolefin-based elastomer, and the outer side of the sheath portion 1007 can be observed by the endoscope 1009 inserted into the endoscopic lumen 1010 through the sheath portion 1007.”) for pressing against the target tissue (Figs. 221-231 tissue 1097a and 1097b);
wherein the distal tip portion (Figs. 221-231 lumen 1013) is engageable with the target tissue (Figs. 221-231 tissue 1097a and 1097b) such that the suction channel overlies a tissue opening (Figs. 221-231 opening between tissue 1097a and 1097b)to engage the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) and suction applied via the suction channel causes the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b) to be drawn into the suction channel to press the first and second target tissue portions (Figs. 221-231 tissue 1097a and 1097b)together ([0642-0645] “…the suture tissues 1097 a and 1097 b are pulled into the treatment lumen 1012 from the side opening 1013 by the suction function or the like provided to the endoscope 1009.”);
wherein the tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200) is configured to pierce (Fig. 227) the target tissue (Figs. 221-231 tissue 1097a and 1097b), and to hold (Fig. 227) the first and second target tissue portions tissue (Figs. 221-231 tissue 1097a and 1097b) together to close the opening in the target tissue (Figs. 221-231 tissue 1097a and 1097b); and
wherein a first control element (Sheath of endoscope 1009) extends from a proximal end (see annotated Fig. 221), coupled with the first actuator (Fig. 221 knobs on endoscope 1009), to the tissue acquisition assembly (Figs. 221-231 endoscope 1009), and a second control element (Figs. 221-231 needle main body 1200) extends from a proximal end (see annotated Fig. 221), coupled with the second actuator (Figs. 141, 221 needle sliders 1043a/b), to the tissue closure assembly (Figs. 221-231 needle 1199 via needle main body 1200).
PNG
media_image2.png
680
894
media_image2.png
Greyscale
While Suzuki discloses the tissue closure system disclosed above, Suzuki fails to teach that the endoscope is a single-use endoscope.
However Gilreath, in the same field of endeavor, teaches a device and system for in-vivo procedures that is a single-use endoscope (Gilreath – [0006] “ The device and system, according to an embodiment of the invention, may be a single-use device or system or may comprise single-use components, essentially eliminating the need for sterilization in between uses, ….”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the tissue centesis system as taught by Suzuki with the teaching of a single use device as taught by Gilreath for the benefit of “essentially eliminating the need for sterilization in between uses” [Gilreath – [0006].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Cooper et al. (US11304769);
Richard Gamble (US2003/0171760);
Lehman et al. (US2004/0034371);
Aznoian et al. (US2004/0158125);
Swanstrom et al. (US2005/0251176);
West et al. (US2012/0271327);
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 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, Michael Carey can be reached on (571) 270-7235. 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.
/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795