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 .
Response to Arguments
Applicant argues in the response filed 09/09/2025 that the 112(a) new matter rejection should be withdrawn since “a person of ordinary skill in the art would recognize with reasonable clarity that the Applicant had possession the limitation ‘each of the plurality of biodegradable stiches being passed directly through one of the first lumen or the second lumen and the monolithic impermeable tube’ based on the original disclosure”. The applicant cites paragraph 54 that states:
The anastomosis protection device/stent/tube 102 may be secured at place with the biodegradable sutures, at the proximal and distal ends of the device (placed from outside the colon), which anchored the anastomosis protection device/stent/tube 102 in place to both prevent migration and create a very effective seal to the colonic wall
The applicant also cites two sources that states it is “a customary mechanism for a suture to secure and anchor a device is by passing the suture through the device”. Therefore the applicant argues “it is implicit that the original disclosure reasonable conveys to one of ordinary skill in the art, considering both the ordinary and customary meaning of the terms and the use of the term within the specification, that the inventor had possession at that time of the later claimed subject matter”.
The examiner does not find the arguments persuasive. It is to be noted the sources were not cited, and/or stated to be “incorporated by reference” in the specification as originally filed. Further it is to be noted that arguments are not taken to be evidence (see MPEP 2145). The sources can be prior art that is known to secure a tube by placing sutures through the device, however it does not provide support that specification as originally filed had possession that the paragraph 54 statement “the tube is secured with suture” would also convey placing the stiches directly through the tube. The specification does not positively state the stiches are placed through the tube. Figure 4a,b shows the stiches can be placed through the lumens but not necessarily through the tube. Prior art does teach other ways a tube can be secured in place by sutures that are not placed directly through the tube. U.S. Patent 4,182,339 to Hardy and U.S. Patent 5,180,392 to Skeie both have teachings of other ways that a device can be “secured at place with sutures at the proximal and distal ends of the device which anchored the anastomosis protection device/stent/tube in place” that does not include placing the sutures directly through the tube. It may be common knowledge that a tube can be secured by having a suture placed directly therethrough but there are other ways to secure the tube. It is therefore not known or inherent that the specification as originally filed supports the limitation that the stiches are passed directly through the tube. The 112(a) rejection is maintained below.
The applicant argues the claim amendment to claim 29 would overcome the 112(a) rejection. The rejection has been withdrawn. However a 112(b) has been made below.
The applicant traverses the rejection with respect to Schmitt in view of Stopek, Li, Coleman, Imran, and Buzerak as evidenced by Woo, Deister, and Umbach that a prima facie case of obviousness has not been established. The applicant seems to argue that prior art does not render obvious the limitation “securing the monolithic impermeable tube in place…using a plurality of biodegradable stiches at the proximal and distal ends of the monolithic tube, where each of the plurality of degradable stiches being passed directly through …the monolithic impermeable tube” since Schmitt fails to teach or render obvious “securing the tube using a plurality of stiches at the proximal and distal ends”, Imran fails to teach “using stiches at the proximal and distal ends of the tube”, Stopek fails to teach “using stiches”, and Woo would not “motivate person because Woo teaches a side-to-end anastomosis instead of an end-to-end anastomosis”. The examiner acknowledges that each prior art lacks teachings of the claim/limitation as a whole, however the examiner maintains the combination of the prior art would render obvious the claim. Schmitt does disclose that a tube can secured using biodegradable stiches where the ends of the tube create a seal with lumens. The stiches are in the middle of the tube, but Schmitt also discloses other options of securing the tube. Imran teaches a device where fasteners are used at the ends of a tube, the securing mechanism can be used on different types of anastomosis connections, and that a suture can be placed through the tube. Therefore the anchoring mechanism of Schmitt can be at the ends instead of the middle and it is known to attach a suture through the tube. Stopek teaches that fasteners can be sutures. Therefore the fasteners used in Schmitt/Imran can be sutures placed through the ends of the tube and lumens. Woo provides evidence that sutures can be used to attach a tube to tissue by placing the suture through the ends of a tube and through tissue. It can be known that it is a common practice to secure a tube in place by placing sutures through ends of the tube and the respective lumens. Therefore the stiches used in Schmitt/Imran/Stopek can be placed through the tube and tissue in order to be able to read on the claim limitations of record. The examiner maintains the rejection below.
Claim Objections
Claim 1 is objected to because of the following informalities: The states of claim 1 is “Previously presented” however there seems to be amendments to claim 1. The status of claim should be “Currently amended”. The status of the clams should be maintained and correct throughout prosecution. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, 21-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, lines 15-17 and claim 22 lines 16-18, each states respectively “each of the plurality of stiches being passed directly through one of the first lumen or the second lumen and the monolithic impermeable tube”. ….
The applicant states the support for the amendments can be found in at least paragraphs 54, figure 4a,b and cites two sources in the arguments filed 09/09/2025 that states it is a known technique for securing an anastomosis by placing sutures through the tube and the lumen. However, the sources were not incorporated by reference in the application as originally filed. Further, arguments are not taken to be evidence. Therefore the sources at best can be prior art that teaches it is known to place sutures through the tube and lumens but not that the application had possession of the specific nature of securing the tube at place with sutures to anchor the tube in place by placing the sutures directly through the tube and lumen. Paragraph 32 supports that “the tube may be sealed with the biodegradable stiches against the walls of the lumen”. Figure 4b does show the stiches placed from outside the lumen but the stiches seem to be through the two ends of the two lumens of the body. The tube does not seem to be shown in figure 4b, let alone the proximal and distal ends of the tube, or even the stiches being placed through the tube. Paragraph 54 does support the “tube may be secured at place with the biodegradable sutures, at the proximal and distal ends of the device, (placed outside the colon), which anchored the anastomosis protection device/stent/tube 102 in place to both prevent migration and create a very effective seal to the colonic wall” but not that the stiches are placed through the tube.
The specification as originally filed does not specifically state/support that the stiches are placed through the tube. The specific nature of how the tube is secured at the ends by the stiches is not disclosed. It can be inferred that an option of securing the tube in place is that the stiches can be placed through the tube to secure the tube. However, there are another mechanisms that a stitch is used to secure a tube where the stich does not go through the tube. U.S. Patent 4,182,339 to Hardy discloses applying stiches around the ends of the lumens (which can read on through the lumen), and then cinching the stich to the ends of a tube. U.S. Patent 5,180,392 to Skeie discloses a groove on a tube where a stich is placed to secure a lumen to the tube but reduces the risk the needle would hit the tube. Since prior art does teach other mechanisms for using a stich to secure ends of a tube to a lumen, as well as teaching away from placing the stich through the lumen, it is NOT INHERENET NOR INFERED that specification as originally filed would support the limitation that the stiches are “passed directly through the tube”. Therefore the limitation is considered new matter.
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.
Claim 29 is 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 29 recites the limitation "using a plurality of biodegradable stiches at the anastomosis" in lines 2-3. Claim 29 is dependent off of claim 22 which claims in lines 13-14 “securing the monolithic impermeable tube in place covering the anastomosis using a plurality of biodegradable stiches…”. It is unclear if the “a plurality of stiches” are the same plurality of stiches of claim 22 or other stiches that are with respect to the location of the “anastomosis”. For examination purpose, the limitation will be interpreted to be “[[a]] the plurality of biodegradable stiches” which will can limit claim 22 but saying they are used at the general anastomosis.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1, 3-8, 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 3,620,218 to Schmitt in view of U.S. Patent Publication 2010/0010517 to Stopek, U.S. Patent 4,667,673 to Li, U.S. Patent Publication 2009/0105733 to Coleman, U.S. Patent Publication 2010/0023132 to Imran, and U.S. Patent 5,356,424 to Buzerak, as evidenced by at least U.S. Patent Publication 2004/0133147 to Woo, U.S. Patent Publication 2019/0314132 to Deister, and U.S. Patent Publication 2018/0078397 to Umbach.
As to claims 1, 8, 21, 22, 28, Schmitt discloses a method for protecting an anastomosis, by an anastomosis system, between at least two lumens of a body (the two ends of the artery 37, or other lumens in col 5 ll. 55-70, which are joined together, figure 1, 2, col. 5 ll. 23-27) comprising: identifying a requirement of creating the anastomosis between a first lumen and a second lumen of the at least two lumens of the body (at least in part in part by 41, and including the user, the acknowledgement of the splice in the artery); creating the anastomosis connecting an end of the first lumen and an end to a second lumen (col. 5 ll. 24-26), placing a monolithic impermeable tube (41) composed of a biodegradable material (col. 2 ll. 6-19, the tube 41 is formed from PGA which is disclosed to be absorbable, and can be impermeable based on the use of PGA of the application invention, see prior art in section 13 below as further evidence) at a level of the anastomosis (figure 1, 2) to cover the anastomosis (figure 1,2), and securing the monolithic impermeable tube in place covering the anastomosis using a biodegradable stitches (39, 42, figure 2, col. 1 ll. 34-35, 40, 41, col. 5 ll. 20-30, 35-70) to form a seal and secure the monolithic impermeable tube to the tissue of each of the first lumen and second lumen (col. 5 ll. 20-30, 35-70, the ends of the vessels are tightly held in place, allow for flow therethrough and minimize tu(r)bulence, which will allow the tube be sealed and secured to the tissue), preventing an anastomotic leak and protecting the anastomosis by preventing luminal contents associated with the at two lumen of the body from contacting the anastomosis and walls of the first lumen and second lumen (figure 2, col. 6 Il. 20-30, col. 5 Il. 55-70 col. 6 Il. 26, the solid strong PGA tube will prevent the contents of the lumens to contact the anastomosis, see prior art Stopek and further prior art below in section 9 below as further evidence).
However, Schmitt is silent about using a delivery system to advance the monolithic impermeable tube within the at least two lumens after creating the anastomosis, the monolithic impermeable tube being pushed over an outermost surface of the delivery system inside the at least two lumens during the anastomosis or after the anastomosis, wherein the monolithic impermeable tube is placed via a transanal placement, and securing the monolithic impermeable using a plurality of biodegradable stiches at the proximal and distal ends of the tube, where the biodegradable stiches are placed trans-abdominally from outside the first lumen and second lumen, and passed directly through one of the first lumen or second lumen and the monolithic impermeable tube to form a seal at the proximal and distal ends of the monolithic impermeable tube against the first lumen and second lumen respectively.
Stopek teaches a similar device and method (lumen anastomosis, abstract), where the body lumens for the anastomosis can be intestinal, vascular or anther body lumen (paragraph 13, 26). Therefore Stopek teaches that tubular organs such as a blood vessel and intestine can have anastomosis concepts applied in a similar fashion. Prior art below in section 13 can provide further evidence that creating an anastomosis in the intestines is similar and can be substituted for as a teaching for an anastomosis in the vascular system or other similar body lumens. Schmitt does disclose in col. 5 ll. 55-63 that device can be used on any of a variety of vessel or body tube. It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the tube of Stopek in intestinal lumens in order for use obtaining an anastomosis in similar body lumens as desired. Li teaches a similar method (anastomosis coupling) where the instrument is introduced into the bowel transanally in order to obviate the need for making and closing a separate opening on the bowel. See prior art below in section 13 that further provides evidence for a transanal placement. It would have been obvious to one of ordinary skill in the art before the effective filing date to place the monolithic impermeable tube of Schmitt via a transanal placement in order to obviate the need for making a closing a separate opening on the bowel when using the tube of Schmitt in the intestines as taught by Stopek.
Coleman teaches a similar device and method (anastomosis method and device, abstract) using a delivery system (20, figure 10-12) comprising one of detachable rigid or semi-rigid tool (paragraph 72, the actuator comprises shafts that apply forces to the tube and detaches from the tube, so the actuator will comprise at least a semi-rigid tool) to advance a tube (10) within at least two lumens (54a,b, figure 23), the monolithic impermeable tube being pushed over an outermost surface of the delivery system (figure 11, 18-20, paragraph 72, 73, the former 72 applies an axial force which will ultimately push the tube into place) inside the at least two lumens during the anastomosis or after the anastomosis for the purpose of effectively delivering the tube to the site of the anastomosis (paragraph 72). Coleman teaches a simple delivery system that has a tube on an outer surface of a delivery system, advancing the tube through the last two lumens via the delivery system, and effectively pushing the tube off in place. Schmitt does not disclose how the tube is delivered. One of ordinary skill in the art would be able to use the teaching of Coleman, using a tube on an outermost surface of a delivery system, and push it off in order to deliver the tube accurately and directly. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to place the tube of Schmitt using a delivery system comprising a detachable rigid or semi-rigid tool, pushing the tube over an outermost surface of the delivery system as taught by Coleman in order for using a delivery system to accurately and directly deliver the tube in in place.
Imran teaches a similar device and method (scaffolding anastomosis, abstract) including securing a tube (10) at the proximal and distal ends of the tube to form a seal at the proximal and distal ends of the tube to form a seal at the first and distal ends of the tube against the first and second lumen respectively (paragraph 29, 30, 33, 34, 35) for the purpose of maintaining alignment of the anastomosis and prevent leakage from the lumen. Imran teaches using retention elements 41 at the ends of a tube will help secure the tube in place in an end to end anastomosis in the bowels. It is to be noted Imran also teaches similar mechanism can be applied to other different types of anastomosis (paragraph 29) and that the scaffold can be placed transanally when deploying the scaffold in the digestive tract (paragraph 11, 44). It would have been obvious to one of ordinary skill in the art before the effective filing date to secure the proximal and distal ends of the tube of Schmitt directly to the first lumen and second lumen respectively to form a seal at the proximal and distal ends in order to maintaining alignment of the anastomosis and prevent leakage from the lumen.
With respect to the securing structure, Stopek teaches a similar device and method (sheath to affix body lumens) using fasteners (S, 42) passed directly through of the first lumen or second lumen and the tube (figure 4, paragraph 52) for the purpose of attaching the tube to the body lumen. Stopek does teach that a suture, staple, or tack can be substituted for one another in order to use a known device to attach the tube to the body lumen. Schmitt does teach that stiches used can be biodegradable and the tube can be secured in place. Woo provides evidence for biocompatible fasteners can be staples or sutures (paragraph 33) can will be used to securely attach a tube to a lumen and securing the ends of the device to the first and second lumens will seal the tube in place (figure 5, paragraph 33). Further, Imran does teach that sutures can be placed into the scaffold/tube (paragraph 48). It is known that a tube can be secured by placing stiches through the ends of the tube and the respective lumens. Using sutures at both ends of the tube will form the seal at the proximal and distal ends of the tube. It would have been obvious to one of ordinary skill in the art before the effective filing date to use biodegradable stiches at the proximal and distal ends of the tube each of which passed directly through one of the first or second lumen respectively and the tube in order to secure the tube of Schmitt and form the seal in order for securely attaching a tube to tissue.
Buzerak teaches a similar device and method (laparoscopic anastomotic suturing device, abstract) having a method step of placing stiches trans-abdominally (col. 4 ll. 18-40, col. 1 ll. 20-30) from outside the lumen and passed directly through lumens at a level of an anastomosis (figure 6a-d, col. 6 ll. 6-41) for the purpose of simplifying the process of suturing and increase the speed and precision at which such stich is made (col. 1 ll. 45-50). Buzerak teaches the transabdominal suturing is placed via laparoscopic suturing (col. 4 ll. 20). Buzerak does teach the need of improving the suturing where the suture device/needle is placed laparoscopically through the abdominal. Buzerak does teach the suturing device can be used on an anastomosis site. The sutures of Schmitt can either be applied from the outside the lumen or from the inside. Using the device of Buzerak can allow the sutures, which are applied through the tube, at the proximal and distal ends tube and through the first and second lumens respectively to be applied precisely and efficiently. It would have been obvious to one of ordinary skill in the art before the effective filing date to place the stiches trans-abdominally from outside the lumen(s) as taught by Buzerak in order for simplifying the process of suturing and increase the speed and precision at which such stich is made.
Prior art Stopek can further provide evidence on a tube can be impermeable in order to acquire desired characteristics of the intended use of the device (paragraph 32). Prior art Deister provides evidence that a similar tube sleeve can have holes to be attached by sutures (figure 3, 7, paragraph 35). Coleman further provides evidence that a suture can help provide a seal of a the tube end (paragraph 64). Prior art Umbach provides evidence on the method steps of creating an anastomosis first, securing it, then sealing (paragraph 9, 11).
For a general summary of rejection 1, Schmitt discloses the identifying step, creating an end to end anastomosis, placing a monolithic biodegradable tube composed of biodegradable material at a level of an anastomosis between two lumens, using biodegradable stiches to secure the tube to first and second lumens, preventing an anastomotic leak, and protecting the anastomosis. Stopek teaches the method can be used in lumens in the digestive tract. Li teaches transanal placement of the tube in the digestive tract. Coleman teaches using a delivery system where a tube is on an outermost surface and can be pushed off in place. Imran teaches securing the proximal and distal ends of the tube to the first and second lumens respectively in order to from a seal at the first and second ends, as well as the transanal placement. Stopek teaches using a stitch as the securing mechanism. Buzerak teaches the trans-abdominal insertion of the stitches from outside the lumens. Other prior art can help to provide evidence on the claim limitations.
As to claim 3, 23, with the method of Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Schmitt discloses the monolithic impermeable the tube degrades within a predefined time period (col. 2 ll. 6-20) and the monolithic impermeable tube comprises an impermeable membrane (col. 5 ll. 20-22). Since the tube is claimed to monolithic, the very nature of the tube is interpreted to be the membrane. The extruded or molded PGS tube of Schmitt will be able to read on the impermeable tube/membrane. Prior art below in section 13 can provide further evidence on the membrane.
As to claim 4, 24, with the method of Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Schmitt discloses comprising facilitating healing of the anastomosis by providing the tube as a physical barrier against the luminal contents (col. 5 ll. 20-28, figure 2). At least prior art below in section 13 can provide further evidence.
As to claims 5, 25, with the method of Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Coleman further teaches the delivery system comprises at least one of an End-to-End Anastomosis (EEA) stapler, a rigid proctoscope, a sigmoidoscope, a colonoscope, or an endoscope detachably attached to the tube through the at least one of a detachable rigid tool or a detachable semirigid tool, wherein the at least one of the detachable rigid tool or the detachable semirigid tool are adapted for advancing the tube through the at least two lumens (paragraph 89, an endoscope can be used with the actuator 20). Prior art below in section 13 can provide further evidence. Imran can also teach/provide evidence of other scopes used to help deliver the device (paragraph 44).
As to claims 6, 26, with the method Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Schmitt discloses the biodegradable material comprises at least one of a polyaxial block copolymer, a Polylactic Acid (PLA), Polyglycolic Acid (PGA), a Poly Lactic-co-glycolic Acid (PLGA), a Polycaprolactone (PCL), a combination of the polyaxial block copolymer and the PGA, or Polyhydroxyalkanoates (PHA) (col. 5 ll. 21).
As to claim 7, 27, with the method of Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Coleman further teaches verifying a position of the monolithic impermeable tube using an imaging technique, wherein the imaging technique comprises an endoscopy, a fluoroscopy, or an ultrasound (paragraph 89) in order to accurately position the device. Imran further teaches using an imaging technique (paragraph 43). It would have been obvious to one of ordinary skill in the art before the effective filing date use the verifying step with an endoscopic, fluoroscopy, or ultrasound imaging technique in order to accurately position the device.
As to claim 29, with the method of Schmitt, Stopek, Li, Coleman, Imran, Buzerak above, Imran further teaches securing the monolithic impermeable tube in place covering the anastomosis further comprises using a plurality of biodegradable stiches at the anastomosis (paragraph 48). The plurality of sutures that are used to secure tube in place are used at the general location of the anastomosis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art can render obvious or provide evidence on the claims of record as listed below: U.S. Patent 2,127,903 to Bowen (similar tube, suturing from outside) (as previously cited as reference F in the form 892 filed 11/28/2023), U.S. Patent 4,182,339 to Hardy (alternative stich securing mechanism) (as previously cited as reference A in the 892 filed 11/08/2024), U.S. Patent 4,899,744 to Fujitsuka (similar tube, suturing from outside) (as previously cited as reference G in the form 892 filed 11/28/2023), U.S. Patent 5,152,769 to Baber (trans-abdominal suturing device/method (as previously cited reference F in the form 892 filed 06/10/2024), U.S. Patent 5,180,392 to Skeie (alternative stich securing mechanism) (as previously cited reference F in the form 892 filed 06/10/2024), U.S. Patent 5,314,435 to Green (transanal placement) (as previously cited as reference B in the 892 filed 06/25/2025), U.S. Patent Publication 2002/0091397 to Chen (tube delivery on outer surface of delivery system) (as previously cited as reference B in the 892 filed 11/08/2024), U.S. Patent Publication 2004/0176751 to Weitzner (suturing from outside lumen) (as previously cited reference I in the form 892 filed 06/10/2024), US. Patent Publication 2007/0142850 to Fowler (alternative stich securing mechanism) (as previously cited as reference H in the form 892 filed 11/28/2023), U.S. Patent Publication 2008/0009936 to Kim (sealing ends of an anastomosis tube) (as previously cited as reference C in the 892 filed 11/08/2024), U.S. Patent Publication 2008/0114385 to Byrum (similar degradable material in a predefined time period) (as previously cited as reference F in the form 892 filed 03/15/2024), U.S. Patent Publication 2008/0215076 to Baker (similar tube, biodegradable material, abdominal approach, sealing ends of the tube)(as previously cited as reference I in the form 892 filed 11/28/2023), U.S. Patent Publication 2008/0302855 to Bilotti (similar access/approach) (as previously cited as reference G in the form 892 filed 03/15/2024), U.S. Patent Publication 2008/0132923 to Fowler (EEA guide) (as previously cited reference A in the 892 filed 11/28/2023), U.S. Patent Publication 2008/0249544 to Brand (sealing ends of an anastomosis tube) (as previously cited as reference D in the 892 filed 11/08/2024), U.S. Patent Publication 2009/0105734 to Gronberg (tube delivery on outer surface of delivery system) (as previously cited as reference E in the 892 filed 11/08/2024), U.S. Patent Publication 2009/0281560 to Wexner (trans-abdominal approach) (as previously cited reference I in the form 892 filed 06/10/2024), U.S. Patent Publication 2013/0079890 to Rousseau (sealing ends of an anastomosis tube) (as previously cited as reference G in the 892 filed 11/08/2024), U.S. Patent Publication 2013/0282103 to Madjarov (sealing ends of an anastomosis tube) (as previously cited as reference H in the 892 filed 11/08/2024), U.S. Patent Publication 2015/0313598 to Todd (similar anastomosis between intestines and blood vessels) (as previously cited as reference C in the 892 filed 06/25/2025), U.S. Patent Publication 2015/0342770 to Howard (tube delivery on outer surface of delivery system) (as previously cited as reference I in the 892 filed 11/08/2024), U.S. Patent Publication 2016/0095599 to Jose (similar biodegradable tube) (as previously cited as reference I in the form 892 filed 03/15/2024), U.S. Patent Publication 2020/0237539 to Manolidis (securing the proximal and distal ends of an anastomosis device) (as previously cited as reference D in the 892 filed 06/25/2025), U.S. Patent Publication 2020/0305860 to Dallolio (similar suture/stich/staple) (as previously cited reference J in the form 892 filed 06/10/2024).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771