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 .
Notice of Amendment
The Amendment filed 6/5/2025 has been entered. Claims 1, 2, 4, 6-17, 19, 21-24 are pending in the application with claims 1, 9-13 amended, claims 3, 5, 18, 20 cancelled, and claim 24 newly added. The previous 35 USC 112 rejection of claims 1, 2, 4, 6-17, 19-23 are withdrawn in light of Applicant’s amendment.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 6-17, 19, 21, 23 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ouchi (US Patent No. 6,503,192).
In regard to claim 1, Ouchi discloses a device (10, Fig. 8) for maintaining colonic air distension (Col. 2, Lines 1-5), comprising:
a body (10) having a longitudinal axis, an inner surface, an outer surface, a proximal end, and an opposed distal end spaced from the proximal end along the longitudinal axis, wherein the body defines a central bore surrounding the longitudinal axis (Fig. 8), wherein the central bore has a diameter (Fig. 8);
a unitary sealing structure (13) coupled to the proximal end of the body, the unitary sealing structure comprising a proximal gasket (12) and a diaphragm (outer diameter of the cover (13)), wherein the proximal gasket defines a central bore having a diameter that is less than the diameter of the central bore of the body (Fig. 8), wherein the proximal gasket is positioned at an apex of the unitary sealing structure (Fig. 8), and wherein the diaphragm extends radially outwardly from the proximal gasket to define an outer diameter beyond the outer surface of the body (Fig. 8) and is configured to form a fluid-tight seal with an anus or a stoma of a subject (Col. 4, Lines 16-23),
wherein:
the device is configured to be advanced over a distal portion of a colonoscope such that portions of the colonoscope pass through the central bores of the proximal gasket and the body of the device, the proximal gasket is configured to form a fluid-tight seal with an outer surface of the colonoscope, the device is configured for selective advancement over the distal portion of the colonoscope in a proximal direction toward the subject such that the unitary sealing structure of the device is positioned to form the fluid-tight seal with the anus or stoma of the subject, and wherein the device is configured for movement in a distal direction to break the fluid-tight seal between the unitary sealing structure and the anus or stoma of the subject to allow air release from the subject while a proximal portion of the colonoscope is positioned within the subject through the anus or stoma of the subject (the device (10) of Ouchi is capable of being used to perform the intended function).
In regard to claim 2, Ouchi teaches further comprising a distal gasket (12) coupled to the distal end of the body of the device (Fig. 9).
In regard to claim 6, Ouchi teaches wherein the body of the device is substantially tubular (Fig. 8).
In regard to claim 7, Ouchi teaches wherein the body of the device has a longitudinal length ranging from about 4 cm to about 15 cm (Col. 1, Lines 61-67).
In regard to claim 8, Ouchi teaches wherein at least a portion of the outer surface of the body of the device is scored or grooved (section (10c) is considered a groove between sections (10h) and (10b) of the body).
In regard to claim 9, Ouchi teaches wherein the diaphragm has an outer diameter that decreases moving in the proximal direction until reaching the proximal gasket (Figs. 5,8 shows the body can have a tapered portion (10d) in which the diaphragm would match the shape of the tapered portion ending at the proximal gasket (12)).
In regard to claim 10, Ouchi teaches wherein the diaphragm has an outer surface with a convex curvature that is configured to be complementary to the anus or stoma of the subject (Fig. 8, the diaphragm matches the shape of the projection (10h) of the body).
In regard to claim 11, Ouchi teaches wherein at least a portion of an underside of the diaphragm is inwardly tapered in the distal direction (the underside of the diaphragm (13) is inwardly tapered in the distal direction at the distal end of the protrusion (10h), Fig. 8).
In regard to claim 12, Ouchi teaches wherein the diaphragm has a longitudinal length of at least 5 mm (Col. 1, Lines 61-67, Fig. 8).
In regard to claim 13, Ouchi teaches wherein the diaphragm has a maximum outer diameter ranging from about 2 cm to about 6 cm (Col. 3, Lines 23-25).
In regard to claim 14, Ouchi teaches wherein the central bore of the body of the device has a diameter ranging from about 12 mm to about 18 mm (Col. 3, Lines 23-25).
In regard to claim 15, Ouchi teaches wherein the central bore of the proximal gasket has a diameter ranging from about 8 mm to about 14 mm (Col. 3, Lines 23-25).
In regard to claim 16, Ouchi teaches wherein the proximal gasket comprises a pliable material (Col. 4, Lines 6-9).
In regard to claim 17, Ouchi teaches further comprising at least one spine (via endoscope (11) inserted within the longitudinal body) extending along the longitudinal axis of the body of the device and configured to provide structural support to the body of the device (Fig. 8).
In regard to claim 19, Ouchi teaches colonoscopy system comprising:
the device (10) according to claim 1 (see rejection of Claim 1); and
a colonoscope (11) extending through central bores of the proximal gasket and the body of the device (Fig. 8).
In regard to claim 21, Ouchi teaches wherein the unitary sealing structure is a single, monolithic piece (Fig. 8).
In regard to claim 23, Ouchi teaches wherein the diaphragm is inwardly tapered in a proximal direction to form a cone shape (Figs. 5,8 shows the body can have a tapered portion (10d) in which the diaphragm would match the shape of the tapered portion ending at the proximal gasket (12)).
In regard to claim 24, Ouchi teaches wherein the body comprises at least one projection (10b) that projects radially outwardly from the outer surface of the body and is configured to prevent entrance of the at least one projection into a body of the subject (Figs. 1,8).
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, 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ouchi (US Patent No. 6,503,192) in view of Davis (US 4,776,845).
In regard to claim 4, Ouchi is silent with respect to further comprising at least one internal gasket coupled to the inner surface of the body of the device between the distal and proximal gaskets, wherein the at least one internal gasket is configured to restrict air flow within the device.
Davis teaches an analogous rectal insert apparatus (11) comprising a working channel (33) for insertion of a colonoscope (23) therethrough. The working channel (33) comprising a seal (21) on an inner surface of the channel for forming a seal about the colonoscope to prevent leakage of insufflation air through the channel.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the device of Ouchi with the additional seal (21) of Davis to form a seal about the colonoscope and prevent any uncontrolled leakage of insufflation gas from the intestine.
Claims 1 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi (US Patent No. 6,503,192) in view of Hattori (JP 2008-183015 A).
In regard to claim 1, Ouchi discloses a device (10, Fig. 4) for maintaining colonic air distension (Col. 2, Lines 1-5), comprising:
a body (10) having a longitudinal axis, an inner surface, an outer surface, a proximal end, and an opposed distal end spaced from the proximal end along the longitudinal axis, wherein the body defines a central bore surrounding the longitudinal axis (Fig. 8), wherein the central bore has a diameter (Fig. 4);
a unitary sealing structure (10h) coupled to the proximal end of the body, the unitary sealing structure a diaphragm (10h), and wherein the diaphragm extends radially outwardly to define an outer diameter beyond the outer surface (10c) of the body (Fig. 4) and is configured to form a fluid-tight seal with an anus or a stoma of a subject (Col. 4, Lines 16-23),
wherein:
the device is configured to be advanced over a distal portion of a colonoscope such that portions of the colonoscope pass through the central bores of the proximal gasket and the body of the device, the proximal gasket is configured to form a fluid-tight seal with an outer surface of the colonoscope, the device is configured for selective advancement over the distal portion of the colonoscope in a proximal direction toward the subject such that the unitary sealing structure of the device is positioned to form the fluid-tight seal with the anus or stoma of the subject, and wherein the device is configured for movement in a distal direction to break the fluid-tight seal between the unitary sealing structure and the anus or stoma of the subject to allow air release from the subject while a proximal portion of the colonoscope is positioned within the subject through the anus or stoma of the subject (the device (10) of Ouchi is capable of being used to perform the intended function).
Ouchi does not expressly teach the unitary sealing structure comprising a proximal gasket, wherein the proximal gasket defines a central bore having a diameter that is less than the diameter of the central bore of the body, wherein the proximal gasket is positioned at an apex of the unitary sealing structure, the diaphragm extends radially outwards from the proximal gasket.
Hattori teaches an analogous colonoscopy aid (10) comprising a body (11) with a central bore extending therethrough. A distal end of the central bore comprises an inflow air blocking portion (96) projecting radially inward from peripheral walls of the central bore for engaging an endoscope inserted therethrough thereby preventing air from escaping the colon (Fig. 1, Par. 71).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the body of Ouchi with the inflow air blocking portion (96) of Hattori thereby preventing air from entering the colon to maintain a negative pressure state (Par. 71-72).
In regard to claim 22, Hattori teaches wherein the body and the unitary sealing structure comprise silicone (Par. 46 teaches of the body formed of a silicon material).
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, 6-17, 19, 21-24 have 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/ Primary Examiner, Art Unit 3795 October 23, 2025