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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after the: 3/20/26 Allowance. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid. Applicant's submission filed on 5/29/26 has been entered.
Information Disclosure Statements
The information disclosure statement(s) (IDSs) submitted on 5/29/26 was/were filed before the mailing date of the current Non Final Rejection. The submission(s) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have being considered and entered by the examiner. However, it is noted that: NPL documents 8-12 were not considered as they are not prior art or an Official Action from related or similar cases issued by a governmental patent office.
Terminal Disclaimer
The terminal disclaimer filed on 4/11/25, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent Numbers 12,059,368; 11,903,865; 10,973,675; and 9,827,135, has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31-32, 34-38, 40-45, 47, and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Rousseau (US 8636810 A1).
As to independent claim 31, Rousseau teaches method of protecting an anastomosis in an intestine, the method comprising: introducing a device (device for protection of intestinal anastomosis) into the intestine through the anal canal of a subject (Abstract,ll.1-8), the device comprising a negative pressure anchor [as negative pressure tube formed between walls of sleeve 130 and sheath 80 walls forming 2nd lumen 200 in fluid connection with an outer surface 134 of sleeve 130 Fig.4B,1 via valves 170 through wall of sleeve 130 Col.5, line 64, to Col.6, line 11), [the negative pressure anchor] comprising:
a sleeve 130 Fig.1,2,4B (tubular member 130 Col.5, line 60; having an inner surface 132 defining a 1st lumen 110/160 Figs.1,2,4B; Col.9,ll.11-14; 160 Col.5,ll.60-65; configured to be disposed in the tissue cavity Col.6,ll.13-14; Col.8,ll.55-56 proximal to a damaged area of the tissue cavity Fig.1,2,4B as undamaged tissue site proximal to damaged area/anastomosis 280 Fig.4B Col.5, line 60); [the sleeve 130] attached to: (the 2nd lumen 200 of a sheath 80 being in sealed fluid connection with the 1st lumen 100/160 of the sleeve 130):
a sheath 80 (of member 70 as inner sleeve of device Fig.2,4B Col.6,ll.13-16) in connection with the sleeve 130 Fig.4B, the sheath 80 forming: a 2nd lumen 200 Fig.4B, where sidewalls 90 and 150 of sheath/member 80 and sleeve 130 bonded or connected together about end perimeters Col.7,ll.32-33 to form 2nd lumen 200 as compartment Col.9, line 10, volume, or cavity 200 Fig.4B Col.7,ll.37-38);.
routing the negative pressure anchor to an anchor site in the intestine across the anastomosis (routing the anchor to an anchor site in the tissue cavity Col.6,ll.13-14; Col.8,ll.55-56 across an anastomoisis as damaged area of the tissue of the cavity Fig.1,2,4B; and
applying a negative pressure to the negative pressure anchor to suck the intestinal wall against an outer surface of the sleeve of the negative pressure anchor such that the device is anchored to the intestinal wall [as peristalsis of the intestine applying negative pressure to negative pressure tube formed between walls of sleeve 130 and sheath 80 walls forming 2nd lumen 200 in fluid connection with an outer surface 134 of sleeve 130 Fig.4B,1 via valves 170 through wall of sleeve 130 Col.5, line 64, to Col.6, line 11) and the sheath extends downstream from the negative pressure anchor and across the anastomosis, thereby protecting the anastomosis [where the distal end 100 [sic: proximal, see 112 rejection above] of the sheath 80, extending distal to the distal end 144 of the sleeve 130 is configured to cover and protect the damaged area of the tissue of the tissue cavity [as bowel anastomosis 280 Fig.2,4B Col.8, lines 61; Col.10, line 26] from content flowing through the 2nd lumen 200 of the sheath 80 and the 1st lumen 100 of the sleeve 130 [where distal end 100 of sheath 80 can be longer than the distal end 144 of sleeve 130 Col.7, lines 28-32, capable of protecting damaged tissue 180 from fecal matter Col.11, lines 16-17];; wherein the sleeve is compressible by normal peristaltic forces of a patient's bowel and thereby remains at the anchor site during peristalsis (Abstract,ll.7-8). As to claim 32, Rousseau teaches wherein the negative pressure anchor further compnses:
(a) a first sealing mechanism [proximal 22/28 [proximal seal member 22 Fig.2 Col.7, lines 46-47; and/or proximal seal 28 Fig.4B Col.7, line 57] disposed at a proximal end 140/12 of sleeve 130 [Fig.2,4B Col.7, lines 46-47,53]; and (b) a second sealing mechanism [distal 22/28 [distal seal member 22 Fig.1,2 Col.7, lines 46-47 and/or distal luminal seal 28 Fig.4B Col.7, lines 46-47,57] disposed at a distal end 144/14 of the sleeve 130 [as tube portion of device 10 Fig.2,1 Col.7, lines 46-47,53].
As to claim 34, Rousseau teaches that a diameter of each of the 1st and 2nd annular sealing mechanisms [as proximal and distal seal members 22/28 (as presented above for claim 31) Fig.2,4B Col.7, lines 46-59] is less than or equal to a diameter of the intestine at the the anchor site in the intestine upstream of the anastomosis Col.8, lines 32-36].
As to claims 35-36, Rousseau teaches that the device further comprises a connector tube 150 with a one-way valve 176 for coupling the negative pressure tube [of lumen 200] to the sleeve 130, the connector tube 150 extending through one of the first annular sealing mechanism 22/28 and the second annular sealing mechanism 22/28 [150 extending between and connected to proximal and distal 22/28 as 1st and 2nd annular sealing mechanisms Fig. 1,4B] and having an opening 174 on the outer side 134 of the sleeve130 [Fig.1,2,4B Col.5, line 64, to Col.6, line 8].
As to claim 37, Rousseau teaches that the sleeve, first and second sealing mechanisms, and sheath are comprised of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymer [sleeve as a polymeric material Col.5, line 14].
As to claims 38 and 40, Rousseau teaches that the negative pressure anchor further comprises a plurality of pressure tubes in fluid connection with the outer side 132 of the sleeve 130 [tubes as openings formed by cuts 174 through sidewall 150 of sleeve 130 Fig.1-2 Col.6, lines 1-2].
As to claim 41, Rousseau teaches wherein the introducing of the device into the intestine through an anal canal of a subject is conducted using a delivery system comprising a semirigid tube pusher, wherein the semi-rigid tube pusher pushes the negative pressure anchor to the anchor site in the intestine upstream of the anastomosis [where tubular membrane/delivery shaft is pushed into position by advancing the tube pusher/delivery feature into catheter of catheter delivery system by squeezing handle to insert anchoring stem into patient’s bowel through the anal canal as lumen to the desired location upstream of the anastomosis Col.10, lines 42-59].
As to claim 42, Rousseau teaches wherein the device further includes a flexible membrane [as flexibl membrane delivery shaft of catheter delivery instrument Col.10, lines 42-46] that encases the negative pressure anchor, wherein the flexible membrane invaginates down a proximal end and out a distal end of the semi-rigid tube pusher [where flexible tubular membrane invaginates down the proximal end and out the distal end of the semi-rigid tube pusher can include where the distal end 100 of the sheath 80 can extend distal to the distal end 144 of the sleeve 130].
As to claim 43, Rousseau teaches wherein the method further comprises: removing the semi-rigid tube pusher and the flexible membrane from the anal canal [where flexible member as device eyelet engaging anchoring feature is detached from tube pusher/delivery shaft and extracted from patient’s body after insertion and placement Col.10, lines 42-64].
As to claim 44, Rousseau teaches wherein the negative pressure anchor further comprises a surface material disposed on the outer surface of the sleeve, wherein the surface material is a stacked mesh matrix, a honey-comb lattice of interconnected channels oriented in a radial fashion around the sleeve, a gauze, a fabric, a three-dimensional woven material, or open-cell foam [as porous foam, braided, or other textile structure Col.5, lines 43, that allows bodily fluids and the like to flow and form pathways into various openings in the outer surface of the device Col.5, lines 44-46].
As to claim 45, Rousseau teaches wherein protecting the anastomosis comprises temporarily protecting the anastomosis, the method further comprising removing the device from the intestine via the anal canal upon healing of the anastomosis (where the device is capable of being removed via the anal canal, as presented above).
As to claim 47, Rousseau teaches wherein the sleeve has a length that is between about 3 cm and about 25 cm [where length of sleeve 130 can be length of device as 2-10 cm, within the claimed range Col.8, lines 37-38; or extend beyond the length of the device as presented above].
As to claim 49, Rousseau teaches wherein the introducing of the device into the intestine through an anal canal of a subject is conducted using an endoscope [where tubular membrane/delivery shaft is pushed into position by advancing the tube pusher/delivery feature using an endoscope into catheter of catheter delivery system by squeezing handle to insert anchoring stem into patient’s bowel through the anal canal as lumen to the desired location upstream of the anastomosis Col.10, lines 42-59]..
As to claim 50, Rousseau teaches wherein the negative pressure anchor is configured to stay in place at the anchor site in the intestine upstream of the anastomosis for an extended period of time until the negative pressure anchor is removed by a doctor through the anal canal [where the port provided at connection at center portion of sleeve/sheath/expanded element 32/14/34 with suction tubes 30/22 Fig. 6 0072, lines 3-12 is capable through suction or drainage tubes 30/22 of provide access and removal from the anal canal for fluid delivery and withdrawal from the anal canal, in order to ensure that after suction is removed from the outer face of the sheath 0017, lines 1-5 to decrease the diameter of the sleeve for removal or insertion 0059, lines 3,5-8].
As to claim 51, Rousseau teaches wherein the method further comprises delivering one of a fluid or a positive pressure to the negative pressure anchor to reduce the negative pressure used to anchor the device to the intestinal wall [where the port provided at connection at center portion of sleeve/sheath/expanded element 32/14/34 with suction tubes 30/22 Fig. 6 0072, lines 3-12 is capable through suction or drainage tubes 30/22 of provide access and removal from the anal canal for fluid delivery as a positive pressure for withdrawal from the anal canal, in order to ensure that after suction is removed from the outer face of the sheath 0017, lines 1-5 to decrease the diameter of the sleeve for removal or insertion 0059, lines 3,5-8]..
As to claim 52, Rousseau teaches wherein the method further comprises removing the negative pressure anchor from the intestine via the anal canal [where the port provided at connection at center portion of sleeve/sheath/expanded element 32/14/34 with suction tubes 30/22 Fig. 6 0072, lines 3-12 is capable through suction or drainage tubes 30/22 of provide access and removal from the anal canal for fluid delivery as a positive pressure for withdrawal from the anal canal, in order to ensure that after suction is removed from the outer face of the sheath 0017, lines 1-5 to decrease the diameter of the sleeve for removal or insertion 0059, lines 3,5-8].
Claims 33 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Rousseau in view of Kleiner (US 2013/0190706 A1).
As to claim 33, Rousseau teaches that the first and second annular sealing mechanisms comprise one or more ribs or flutes [Col.5, lines 51-53] placed on each end of the sleeve with an orientation directed away from a center of the sleeve [where ribs or flutes provided at ends of sleeve 130 as part of outer member 120 Col.5, lines 54-55 Fig. 1-6, as providing a radial cross section Col.5, lines 52-53 and made of flexible or elastic material Col.5, lines 58, such that the one or more tapered ribs or flutes would be capable of lying flat against the undamaged tissue site when negative pressure is delivered through the pressure tube [where external source of negative pressure Col.9, lines 53-54 and/or compression/peristaltic contraction/release of intestinal lumen 276 Col.9, lines 1-2 creates negative pressure Col.9, lines 37-39 on pressure tube around outer surface of sleeve 130 formed between outer surface 134 of sleeve/outer member 130 and first and second sealing mechanisms 22 and /or 28 Fig. 4B], and the sleeve/outer member 130 of device expands, conforms, and seals outer surface of the sleeve along with luminal wall 272 of intestine 27 Fig. 6 Col.9, lines 20-22, which would necessarily making the flutes or ribs lie flat against the inner surface of the tissue cavity as the luminal wall surface Fig. 5]. Rousseau does not teach that the ribs or flutes of the sealing mechanisms are two or more tapered fins. However, Kleiner teaches that the ribs or flutes [of the sealing mechanisms] are shaped in the form of two or more tapered fins [as portion of outer surface 32 as shown and labeled 29 as two or more tapered fins 29 as shown in Fig. 2, as extending into pressed against the wound as part of endoluminal surface 31 Fig. 2 0057, lines 1-5 to expand the sleeve 32/sheath 14 using an additional, second anchoring element as expanded element 34 into pressed contact with the endoluminal surface to provide a proper seal 0062, lines 4-6]. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first anchoring element of Rousseau with the second anchoring element of Kleiner, and one of skill would have been motivated to do so, in order to expand the sleeve /sheath using an additional, second anchoring element as an expanded element into pressed contact with the endoluminal surface to provide a proper seal.
As to claim 46, Rousseau does not teach wherein the sheath has a length that allows it to extend outside the anal canal.
However, Kleiner teaches that the sheath has a length that allows it to extend outside the anal canal [where the port provided at connection at center portion of sleeve/sheath/expanded element 32/14/34 with suction tubes 30/22 Fig. 6 0072, lines 3-12 that is capable through suction or drainage tubes 30/22 of provide access and removal from the anal canal for fluid delivery and withdrawal from the anal canal, in order to ensure that after suction is removed from the outer face of the sheath 0017, lines 1-5 to decrease the diameter of the sleeve for removal or insertion 0059, lines 3,5-8]. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Rousseau with the out of the anal canal removal/access of Kleiner, and one of skill would have been motivated to do so, in order to ensure that when suction is removed to the outer face of the sheath to decrease diameter of the sleeve from contact with the endolumenal surface/lumen, the device can be removed from the anal canal.
Claims 39 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Rousseau in view of Belson (US 7338505 B2).
PNG
media_image1.png
269
532
media_image1.png
Greyscale
As to claim 39, Rousseau does not teach wherein the device further includes an irrigation system in fluid connection with the pressure tube, wherein the irrigation system introduces a fluid into the pressure tube for irrigation.
PNG
media_image2.png
197
443
media_image2.png
Greyscale
However, Belson teaches a endoscopic device 102 with pressure tube 100 that performs a colon anastomosis Col.3,ll 7-8, wherein the device comprises expandable members 108 a gripping mechanism 110 with a negative pressure/vacuum gripper thru a plurality of circumferentially located ports in the proximal 106 and distal 104 components that hold the device in place in the colon Fig.2 Col.5,ll.53-67;
wherein the device further includes an irrigation system 117/119 Fig.6 in fluid connection with the pressure tube 100 Fig.6, wherein the irrigation system introduces a fluid into the pressure tube for irrigation (Col.8,ll.2-4), in order to clean out the device in use such as to clear blockages or reduced waste flow.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Rousseau with the irrigation system of Belson, and one of skill would have been motivated to do so, in order to clean out the device in use such as to clear blockages or reduced waste flow.
As to claim 48, Rousseau and/or Belson do not specifically teach wherein the device further comprises a collection bag in fluid connection with the sheath, wherein the collection bag is configured to receive GI content flowing through the sheath. However it would have been obvious to provide a collection bag in fluid connection with the sheath to receive GI content flowing through the sheath, where Belson teaches that the device further includes an irrigation system 117/119 Fig.6 in fluid connection with the pressure tube 100 Fig.6, wherein the irrigation system introduces a fluid into the pressure tube for irrigation (Col.8,ll.2-4), in order to clean out the device in use such as to clear blockages or reduced waste flow, such that one of skill would see the advantage of collecting the waste after irrigation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri. 11 am to 6 pm EST. The direct fax number is (571) 270-4689. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/
Primary Examiner, Art Unit 3781
Prosecution Insights