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 Amendment
In response to the amendment filed on 8/20/2025, claims 1, 3, and 14 have been amended, claim 17 is cancelled, claims 20-21 are newly added, thus claims 1-16 and 18-21 are pending.
The amendment to claim 3 to remedy the 112(b) rejection has been acknowledged and the rejection has been withdrawn.
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument of, “Iyer explicitly discloses that luminal narrowing is considered a failure mode of the vascular system that must be prevented. See Iyer at ¶¶ 11, 27, and claims 20-21. One of ordinary skill in the art would recognize that modifying Iyer’s sleeve to include a rib that provides a radial inward force against the lumen would result in narrowing the lumen. As such, when Iyer is considered as a whole, one of ordinary skill in the art would recognize that Iyer teaches away from the proposed modification, and Stopek fails to remedy the deficiencies of Iyer. Stopek does not teach or suggest “the rim configured to provide a radial force inward against the lumen of the body. Therefore, one of ordinary skill in the art would not find it obvious to modify Iyer based on the teachings of Stopek.”, examiner respectfully disagrees. Stopek discloses in paragraph 44, “Additionally, the volume of fluid may be adjusted to apply a specific amount of pressure to a body lumen wall. For example, in patients whose tissue is weaker or less compliant, less radial force (on exerted on tissue) may be desired by the surgeon.”. This allows for the amount of pressure to be modified while still providing the rim with a proper amount of securing force. Furthermore, because Iyer does not disclose the "amount" of narrowing that Iyer considers a failure and with the adjustability of the narrowing due to the adjustability of the volume, and therefore the adjustability of the "narrowing" of the lumen, Stopek does not teach away from the combination as set forth in the rejection above. Furthermore, Stopek discloses in Fig. 2b section 22d having an inward convex surface that would impart an inward radial force. Therefore, Stopek would remedy the deficiencies of Iyer and would read on the claim limitations of claim 9 and 14. Lastly, applicant has not provided any evidence to prove or suggest the device of Iyer with the rim of Stopek would not operate as intended. Merely, saying that the modification would result in the inoperability of the device is not sufficient to show inoperability of the device. Furthermore, the examiner notes that the arguments of the attorney can not take place of evidence. See In Re Schulze, 346, F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965).
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 20030113359 A1 Iyer et al. (hereinafter Iyer) in view of US 5720755 A Dakov.
Regarding claim 1, Iyer discloses a method to prevent leakage between at least two lumens of a patient’s body during surgery (paragraph 27-30, 37, 39, 41), the method comprising: positioning a tubular device 26 (Fig. 9) over a lumen of a first lumen portion 28 (Fig. 9, paragraph 63, 73, tubular device 26 is a tube placed over first lumen portion 28 which is a venous structure with arrow 34 illustrating the direction of blood flow, therefore first lumen portion 28 has a lumen), the tubular device formed as one piece and having a first end opening, a second end opening, and a lumen extending through an entire length of the tubular device (Fig. 9, paragraph 63, 73, tubular device 26 is a sheet modified into a tube (cylinder) having a first end opening and second end opening and a lumen to receive venous and arterial structures as seen in Fig. 9); attaching a second lumen portion 30 (Fig. 9, paragraph 73) to the first lumen portion to form an anastomotic site (Fig. 9, paragraph 73, fistulae 32 is the anastomotic site where first lumen portion 28 and second lumen portion 30 meet), the device extending over the second lumen portion (as seen in Fig. 9); and securing the device to the first lumen portion utilizing a suture such that an inner wall of the device extends across the anastomotic site (paragraph 63, the tubular device is secured using sutures), the tubular device including a treatment or healing substance adhered thereto (abstract, paragraph 38-39, 63).
Iyer is silent on wherein the first lumen portion and the second lumen portion comprise a portion of the patient's gastrointestinal tract.
However, Dakov teaches a tubular suturing device for anastomosing tubular structures such as the severed ends of blood vessels, intestines, bile ducts, urinary ducts and other tubular organs (abstract, col. 1 line 10-14). In essence, Dakov teaches that it is known that suturing devices can be used on both blood vessels and gastrointestinal tracts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Iyer with the teachings of Dakov to achieve wherein the first lumen portion and the second lumen portion is used on a portion of the patient's gastrointestinal tract in order to provide a suturing device that has the flexibility to suture the ends of blood vessels and structures within the gastrointestinal tract. Furthermore, it would have been obvious to one of ordinary skill in the art to modify the method taught by Iyer to be used in a tubular structure of the gastrointestinal tract, as taught by Dakov, since Dakov discloses that the same device can be used in the treatment of blood vessels and gastrointestinal tracts.
Claims 2-3, are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Dakov and further in view of 20100010518 A1 Stopek et al. (hereinafter Stopek).
Regarding claims 2-3, the combination of Iyer and Dakov teaches the limitations of claim 1.
The combination is silent on wherein the tubular device has a rim, and the suture is placed on the rim (claim 2), and wherein the rim provides a radial force against the lumen of the first lumen portion (claim 3).
However, Stopek teaches a device for use with an anastomosis for prevention of fluid leaks (paragraph 2) that comprises a rim 22 (Fig. 2a), where a suture is placed on the rim (Fig. 2b, paragraph 45, section 22c of rim 22 allows for fixation of the device to a body lumen via a suture), and wherein the rim provides a radial force against the lumen of a first lumen portion (paragraph 46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Iyer with Dakov with the teachings of Stopek to achieve wherein the tubular device has a rim, the suture is placed on the rim and wherein the rim provides a radial force against the lumen of the first lumen portion in order to help retain the device in position disclosed by Stopek (paragraph 46).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Dakov and further in view of US 20040054405 A1 Richard et al. (hereinafter Richard).
Regarding claim 4, the combination of Iyer and Dakov teaches the limitations of claim 1.
The combination is silent on wherein the suture further provides a seal.
However, Richard teaches a device for connecting two lumen portions of a patient’s body and wherein sutures are used to join a lumen portion to the device (paragraph 33, 50) and the suture further provides a seal (paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Iyer with Dakov with the teachings of Richard to have wherein the suture further provides a seal in order to provide a tight seal between the device and body lumen portion and minimize exsanguination as disclosed by Richard (paragraph 6).
Claim 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Dakov and further in view of US 20080255650 A1 Kelley.
Regarding claims 5-6, the combination of Iyer and Dakov teaches the limitations of claim 1.
The combination is silent on wherein the healing substance is a growth factor (claim 5), and wherein the growth factor comprises cellular proteins that assist in cellular proliferation and differentiation (claim 6).
However, Kelley teaches a device for connecting two lumen portions of a patient’s body and wherein the device includes a healing substance that is a growth factor and wherein the growth factor comprises cellular proteins that assist in cellular proliferation and differentiation (paragraph 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Iyer with Dakov with the teachings of Kelley to have the healing substance be a growth factor and the growth factor comprises cellular proteins that assist in cellular proliferation and differentiation, in order to promote healing as disclosed by Kelley (paragraph 31).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Dakov and further in view of US 20170151049 A1 La Francesca et al. (hereinafter La Francesca).
Regarding claims 7-8, the combination of Iyer and Dakov teaches the limitations of claim 1.
The combination is silent on wherein the tubular device is formed of tissue engineered material (claim 7) and wherein the tissue engineered material comprises colon cells (claim 8).
However, La Francesca discloses a tubular scaffold structure (paragraph 12) that uses tissue engineered material to enable the regrowth of engineered tissue, including colon tissue (paragraph 7, 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Iyer with Dakov with the teachings of La Francesca to achieve wherein the tubular device is formed of tissue engineered material and wherein the tissue engineered material comprises colon cells in order to restore gastrointestinal continuity as disclosed by La Francesca (paragraph 4).
Claims 9, 11-12, 14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of 20100010518 A1 Stopek et al. (hereinafter Stopek).
Regarding claim 9, Iyer discloses a method to seal a perforation in a body lumen (paragraph 27-30, 37, 39, 41), the method comprising: positioning a tubular device 26 (Fig. 9) over the body lumen (Fig. 9, paragraph 63, 73, tubular device 26 is a tube placed over venous structure 28 and arterial structure 30 with arrow 34 illustrating the direction of blood flow, therefore structures 28, 30 have a lumen)
Iyer is silent on the tubular device having a rim having an enlarged diameter to provide a radial force against the lumen; and securing the tubular device to a wall of the body lumen utilizing a suture.
However, Stopek teaches a device for use with an anastomosis for prevention of fluid leaks (paragraph 2) that comprises a rim 22 (Fig. 2a), where a suture is placed on the rim (Fig. 2b, paragraph 45, section 22c of rim 22 allows for fixation of the device to a body lumen via a suture), and wherein the rim has an enlarged diameter (as seen in Fig. 2a-b) to provide a radial force against the lumen (paragraph 46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Iyer with teachings of Stopek to achieve wherein the tubular device has a rim, the rim has an enlarged diameter to provide a radial force against the lumen and securing the tubular device to a wall of the body lumen using a suture in order to help retain the device in position as disclosed by Stopek (paragraph 46).
Regarding claim 11, the combination of Iyer and Stopek teaches the limitations of claim 9, and Stopek further teaches wherein the suture is applied only to the rim of the tubular device (Fig. 2b, paragraph 45, section 22c of rim 22 allows for fixation of the device to a body lumen via a suture).
Regarding claim 12, the combination of Iyer and Stopek teaches the limitations of claim 9, and Iyer further teaches applying a healing or treatment substance to an inner wall of the tubular device prior to insertion into the first intestinal, arterial, or cellular lumen portion, the substance applied at least at a region adjacent the region adjacent the anastomotic site (paragraph 38-39, 63).
Regarding claim 14, Iyer teaches a device to limit leakage of a lumen of a body (paragraph 27-30, 37, 39, 41), the device 26 (Fig. 9) comprising: a tubular body (paragraph 63, 73, tubular device 26 is a tube as seen in Fig. 9) having a top portion, a bottom portion, and an intermediate portion between the top portion and the bottom portion (see annotated Fig. 9 below); a lumen extending from the top portion to the bottom portion (as seen in Fig. 9, paragraph 63, device is a tube (cylinder), therefore has a lumen extending from top portion to bottom portion); wherein the device is configured to be placed over a lumen of a first lumen portion 28 (Fig. 9, paragraph 63, 73, tubular device 26 is a tube placed over first lumen portion 28 which is a venous structure with arrow 34 illustrating the direction of blood flow, therefore first lumen portion 28 has a lumen) and a lumen of a second lumen portion 30 (Fig. 9, paragraph 63, 73, tubular device 26 is a tube placed over second lumen portion 30 which is a arterial structure with arrow 34 illustrating the direction of blood flow, therefore second lumen portion 30 has a lumen),
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Iyer is silent on the device having a rim at the edge of the top portion, the rim configured to provide a radial force inward against the lumen of the body, and the device is configured to be held in place by a suture.
However, Stopek teaches a device for use with an anastomosis for prevention of fluid leaks (paragraph 2) that comprises a rim 22 (Fig. 2a) at a top portion of the device, the rim having section 22d having an inward convex surface (22d, Fig. 2b) that would impart an inward radial force, and where a suture is placed on the rim (Fig. 2b, paragraph 45, section 22c of rim 22 allows for fixation of the device to a body lumen via a suture).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Iyer with teachings of Stopek to achieve wherein the tubular device has a rim at the edge of the top portion of the device, the rim configured to provide a radial force inward against the lumen of the body, and securing the tubular device to a wall of the body lumen using a suture in order to help retain the device in position as disclosed by Stopek (paragraph 46).
Regarding claim 18, the combination of Iyer and Stopek teaches the limitations of claim 14. Iyer does not specifically disclose wherein the device is secured via attachment of the intermediate portion. However, Iyer teaches the device is anchored to the anastomotic site by suturing (paragraph 30) and the device can be made more adhesive to the outside vascular wall (paragraph 34). It would have been within the capability of someone with ordinary skill in the art through routine experimentation and optimization to secure the device via attachment of the intermediate portion in order to provide a more secure and reliable attachment.
Regarding claim 19, the combination of Iyer and Stopek teaches the limitations of claim 14, and Iyer and Stopek further teaches wherein the device is asymmetrical (paragraph 63 of Iyer, device can be of other geometrical shapes; paragraph 62 of Stopek, device can be of other shapes including, but not limited to, elliptical, conical, polygonal and rectangular).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Stopek and further in view of Richard.
Regarding claim 10, the combination of Iyer and Stopek teaches the limitations of claim 9.
The combination is silent on wherein the suture provides a seal.
However, Richard teaches a device for connecting two lumen portions of a patient’s body and wherein sutures are used to join a lumen portion to the device (paragraph 33, 50) and the suture provides a seal (paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of Richard to have the suture provide a tight seal between the device and body lumen portion to minimize exsanguination as disclosed by Richard (paragraph 6).
Regarding claim 16, the combination of Iyer and Stopek teaches the limitations of claim 14, and Stopek further teaches wherein the rim is configured to receive a suture for attachment of the rim to the lumen (Fig. 2b, paragraph 45, section 22c of rim 22 allows for fixation of the device to a body lumen via a suture).
The combination is silent on wherein the suture provides a seal.
However, Richard teaches a device for connecting two lumen portions of a patient’s body and wherein sutures are used to join a lumen portion to the device (paragraph 33, 50) and the suture provides a seal (paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of Richard to have the suture provide a tight seal between the device and body lumen portion to minimize exsanguination as disclosed by Richard (paragraph 6).
Claim 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Stopek and further in view of La Francesca.
Regarding claim 13, the combination of Iyer and Stopek teaches the limitations of claim 9.
The combination is silent on wherein the tubular device is formed of tissue engineered materials.
However, La Francesca discloses a tubular scaffold structure (paragraph 12) that uses tissue engineered material to enable the regrowth of engineered tissue (paragraph 7, 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of La Francesca to achieve wherein the tubular device is formed of tissue engineered material in order to restore gastrointestinal continuity as disclosed by La Francesca (paragraph 4).
Regarding claim 15, the combination of Iyer and Stopek teaches the limitations of claim 14 as above.
The combination is silent on wherein the device comprises a tissue engineered material.
However, La Francesca discloses a tubular scaffold structure (paragraph 12) that uses tissue engineered material to enable the regrowth of engineered tissue (paragraph 7, 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of La Francesca to achieve wherein the device is formed of tissue engineered material in order to restore gastrointestinal continuity as disclosed by La Francesca (paragraph 4).
Claim 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer in view of Stopek and further in view of Dakov.
Regarding claim 20, the combination of Iyer and Stopek teaches the limitations of claim 9.
The combination is silent on wherein the body lumen comprises a portion of a gastrointestinal tract.
However, Dakov teaches a tubular suturing device for anastomosing tubular structures such as the severed ends of blood vessels, intestines, bile ducts, urinary ducts and other tubular organs (abstract, col. 1 line 10-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of Dakov to achieve wherein the body lumen comprises a portion of a gastrointestinal tract in order to provide a suturing device that has the flexibility to suture the ends of blood vessels and structures within the gastrointestinal tract.
Regarding claim 21, the combination of Iyer and Stopek teaches the limitations of claim 14.
The combination is silent on wherein the lumen of the body is a portion of a gastrointestinal tract.
However, Dakov teaches a tubular suturing device for anastomosing tubular structures such as the severed ends of blood vessels, intestines, bile ducts, urinary ducts and other tubular organs (abstract, col. 1 line 10-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Iyer with Stopek with the teachings of Dakov to achieve wherein the lumen of the body is a portion of a gastrointestinal tract in order to provide a suturing device that has the flexibility to suture the ends of blood vessels and structures within the gastrointestinal tract.
Conclusion
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 KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/ Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771