DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 10th, 2025 has been entered.
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.
Claims 1, 4-5, 7-11, 16, 18-19, 22-24, 27, 31-34, 36, 91, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Fong (U.S. Publication 2017/0071780) in view of Lattouf (U.S. Publication 2008/0249504) and in view of Yeung (U.S. Publication 2018/0070800) and in view of Chase (U.S. Patent 2,821,190) and in view of Lenker (U.S. Publication 2004/0147864).
Fong discloses a device (for example see Figure 1) comprising:
(claim 1) a sleeve (116) including
(claim 1) an inner surface defining an open central lumen (118) extending through the sleeve from a first end to a second end
(claim 1) wherein the open central lumen is configured to allow enteric contents flowing through a bowel lumen to pass through the sleeve
(claim 1) a sleeve body (102) configured to be disposed in a bowel lumen proximal to a damaged area of tissue of the tissue cavity (for example see paragraph 28)
(claim 1) wherein the sleeve body extends along the first end of the sleeve (element 116 is shown being inserted to the distal end of element 102; for example see Figure 1, for example paragraph 76)
(claim 4) wherein the sleeve body is coextensive with the sleeve
(claim 5) wherein the sleeve body is on a proximal end of the sleeve
(claim 91) wherein the sleeve body is configured to stay in place at an anchor site in a bowel lumen proximal to a damaged area of tissue of the bowel lumen during peristalsis of a patient’s bowel while in a bowel lumen (for example see paragraph 28)
(claim 33) wherein the sleeve includes a length that allows it to extend outside a bowel lumen
(claim 34) wherein the lumen of the sleeve is capable of being compressed by normal peristaltic forces of a patient’s bowel while in a bowel lumen (paragraphs 19 and 101)
(claim 36) wherein the sleeve comprises silicone (paragraph 19)
(claim 1) a first sealing mechanism (108) disposed at the proximal end of the sleeve body
(claim 1) wherein the first sealing mechanism includes an external surface
(claim 22) wherein the first sealing mechanism has an annular outer diameter greater than an annular outer diameter of the open-cell foam (paragraph 17)
(claim 34) wherein the first sealing mechanism is capable of being compressed by normal peristaltic forces of a patient’s bowel (paragraphs 19 and 101)
(claim 1) a second sealing mechanism (110) disposed at the distal end of the sleeve body
(claim 1) wherein the second sealing mechanism includes an external surface
(claim 1) wherein the sleeve body and the sealing mechanisms are configured to form a seal between the external surfaces of the sealing mechanisms, the outer surface of the sleeve body, and the inner surface of a bowel lumen while in a bowel lumen
(claim 22) wherein the second sealing mechanism has an annular outer diameter greater than an annular outer diameter of the open-cell foam (paragraph 17)
(claim 34) wherein the second sealing mechanism is capable of being compressed by normal peristaltic forces of a patient’s bowel (paragraphs 19 and 101)
(claim 1) open-cell foam (120) disposed on an outer surface of the sleeve body
(claim 1) wherein the open-cell foam is between the first and second expandable sealing mechanisms
(claim 16) wherein the open-cell foam is polyvinyl alcohol (paragraph 16)
(claim 18) wherein the open-cell foam has a thickness of between 2 mm and 150 mm (paragraph 16)
(claim 1) a plurality of lumens extending from the first end of the sleeve to the second end of the sleeve including
(claim 1) negative pressure lumen (112) in communication with the sleeve body configured to provide a negative pressure to the sleeve body
(claim 8) wherein the application of negative pressure creates a frictional force that resists displacement of the sleeve body (see abstract)
(claim 9) wherein the negative pressure via the negative pressure lumen is configured to bring the open-cell foam and the external surfaces of the sealing mechanisms into contact with an inner surface of a bowel lumen creating a frictional force that resists displacement of the sleeve body (for example see paragraphs 74-76)
(claim 7) a contrast dye lumen (paragraph 89; for example see Figure 18)
(claim 1) a flushing lumen (paragraph 152)
(claim 24) a collection bag (paragraphs 23, 76, and 123; the bas is attached at the end of the sleeve farthest from the sleeve body, i.e. the distal end) disposed at a distal end of the sleeve and configured to manage enteric contents carried from the device
(claim 27) a scope adapter (a releasable clip; paragraphs 25 and 148-149) configured to connect the sleeve to an endoscope
(claim 31) a negative pressure source (paragraph 18)
(claim 31) wherein the negative pressure applied maintains a constant or variable pressure between 50 mmHg to 200 mmHg (paragraph 18)
Fong fails to disclose the device wherein the first sealing mechanism is expandable and surrounds the sleeve body, such as a balloon (claims 1 and 19), wherein the second sealing mechanism is expandable and surrounds the sleeve body, such as a balloon (claims 1 and 19), wherein the sealing mechanisms include an internal surface and an opening (claim 93), the sleeve including a plurality of fluid lumens (claim 1), such as a proximal fluid lumen and distal fluid lumen (claim 1), the plurality of lumens being within a portion of the internal wall of the sleeve body (claim 1), wherein the portion of the internal wall extends into the open central lumen (claim 1), wherein the negative pressure lumen is configured to provide pressure via a plurality of outlet ports (claim 32), the sleeve having a column strength of about 3.0 lbs. to 6.0 lbs. (claim 23), and the fluid for the expandable sealing mechanisms being a non-compressible fluid (claim 10), such as saline (claim 11).
Regarding the sealing mechanisms being expandable balloons and the sleeve including a plurality of fluid lumens, Fong discloses the device as discussed above comprising a sleeve, a first sealing mechanism, a second sealing mechanism, and negative pressure in order to provide a seal between the device and a tissue cavity. Lattouf teaches a device (for example Figure 2) comprising a sleeve (30) including a lumen (paragraph 28 discloses 30 as a tubular body), a sleeve body (32), a first expandable sealing mechanism (36) at an end of the sleeve body, and a second expandable sealing mechanism (38) at an opposite end of the sleeve body, wherein the sleeve includes a plurality of fluid lumens (44 and 46; paragraph 36), such as a distal fluid lumen (44) and a proximal fluid lumen (46), that provide fluid to the sealing mechanisms and wherein the sealing mechanisms are expandable elastomeric balloons (paragraph 30) in order to provide a seal between the device and a tissue cavity. Because both the device of Fong and the device of Lattouf discloses devices comprising a sleeve, a first sealing mechanism, and a second sealing mechanism, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute the first and second sealing mechanisms of one device for the first and second sealing mechanisms of the other device in order to achieve the predictable results of providing a seal between the device and a tissue cavity.
Regarding the plurality of lumens being within the internal wall of the sleeve, Yueng teaches a device (for example see Figure 1) comprising a sleeve including a lumen (132), and a plurality of fluid lumens, such as a negative pressure lumen (137; for example Figure 3H), a first expandable sealing mechanism (for example 124) including a first fluid lumen (136), a second expandable sealing mechanism (for example 122) including a second fluid lumen (136; paragraph 99), wherein the plurality of lumens (132, 136, 137, etc.) are provided within an internal wall of the sleeve in order to provide a smaller profile device. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf wherein the plurality of lumens are within the internal wall of the sleeve in view of Yueng in order to provide a smaller profile device.
Regarding the negative pressure lumen including a plurality of outlet ports, Yueng teaches a device (for example see Figure 1) comprising a sleeve including a lumen (132), a negative pressure lumen (137; for example Figure 3H), first expandable sealing mechanism (for example 124) including a first fluid lumen (136), a second expandable sealing mechanism (for example 122) including a second fluid lumen (136; paragraph 99), wherein the negative pressure lumen includes a plurality of outlet ports (146; paragraph 138) in order to provide even pressure about the sleeve. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf as further modified by Yueng wherein the negative pressure lumen includes a plurality of outlet ports in view of Yueng in order to provide even pressure about the sleeve.
Regarding the sleeve having a column strength of about 3.0 lbs. to 6.0 lbs., the device of Fong as modified by Lattouf as further modified by Yueng discloses a device wherein the sleeve has a column strength high enough to be inserted into the bowel of a patient (for example see disclosure of Fong) meeting the general conditions of the claims, i.e. the sleeve having a column strength that is high enough to prevent collapse during insertion of the device. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf as further modified by Yueng wherein the sleeve has a column strength of about 3.0 lbs. to 6.0 lbs., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105, USPQ 233.
Regarding the expandable sealing mechanisms surrounding the sleeve body and the sealing mechanisms including an internal surface and an opening, as discussed above the device of Fong as modified by Lattouf as further modified by Yueng discloses a device including expandable sealing mechanisms, i.e. balloons, that are positioned on the sleeve body, but the device of Fong as modified by Lattouf as further modified by Yueng does not explicitly show the balloons surrounding the sleeve body. Lenker teaches a device comprising a sleeve body (22) including an open central lumen, a first sealing mechanism (38), a second sealing mechanism (44), and a plurality of fluid lumens including a fluid lumen (34) to provide fluid to the sealing mechanisms, wherein the sealing mechanisms include an internal surface and an opening coinciding with the open central lumen such that the sleeve body extends radially around the internal surfaces of the sealing mechanisms so the sealing mechanisms surround the sleeve body (claims 1 and 93; for example see Figure 3). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf as further modified by Yueng wherein the expandable sealing mechanism surround the sleeve body in view of Lenker, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an expandable sealing mechanism on a sleeve body. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the portion of the internal wall including the fluid lumens extending into the open central lumen, Chase teaches a device comprising a sleeve body (10) including an open central lumen and a lumen (14) within a portion of an internal wall of the sleeve body, wherein the portion of the internal wall extends into the open central lumen. It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf as further modified by Yueng as further modified by Lenker wherein the portion of the internal wall including the plurality of fluid lumens extend into the open central lumen in view of Chase, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a portion of an internal wall of a sleeve body. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the fluid for the sealing mechanisms being a non-compressible fluid, such as saline, Lenker teaches a device (for example see Figure 3) comprising a first expandable member (38) and a second expandable member (44), wherein the expandable members are expanded using a non-compressible fluid, such as saline (paragraph 10). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Fong as modified by Lattouf as further modified by Yueng as further modified by Lenker as further modified by Chase wherein the fluid to expand the expandable sealing mechanisms are a non-compressible fluid, such as saline, in view of Lenker, since it has been held to be within general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant's arguments filed November 10th, 2025 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the limitations and claims added by the amendment, which are discussed above in the new grounds of rejection provided by the examiner.
Allowable Subject Matter
Claims 38, 92, and 94 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775