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 .
This Office Action is in response to the amendments dated January 14, 2026.
Claims 1 and 5-20 are pending.
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 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fujifilm (JP2011-10950) in view of Farhadi (US 2015/0105621).
Regarding Claim 1, Fujifilm discloses:
An overtube for an endoscope, comprising:
a tube body (20) having a main lumen (23) through which the endoscope is inserted (see Fig. 7) and an air-supply lumen (32) through which gas flows;
a fixing balloon (25) provided on an outer peripheral surface of a distal end of the tube body (see Fig. 7), expandable outward from the outer peripheral surface and contractible toward the outer peripheral surface (balloon 25 expands and contracts relative to the outer peripheral surface of 20);
an air supply device (30) configured to send the gas to the air-supply lumen (see Fig. 2; 30 supplies fluid to the balloon); and
an airtight valve unit (62) having a tubular portion communicating with the main lumen at a rear end of the tube body (see Fig. 7 showing 62 within the main lumen 23), the airtight valve unit closing the gap between the endoscope inserted through the tubular portion into the main lumen and an inner peripheral surface of the tubular portion (shown in Fig. 7 with 62 holding endoscope 10).
Fujifilm does not explicitly disclose wherein the tube body is a multi-lumen body where each of the main lumen and the air-supply lumen extend parallel to each other and to a longitudinal axis of the multi-lumen tube body. Farhadi teaches a multi-lumen body with a main lumen and air supply lumen that run parallel to each other (see Fig. 12 showing main lumen with 91 inserted therein and air supply lumen 23). The Examiner also notes that a standard catheter with a balloon is known to have a central lumen and a fluid supply lumen for the balloon. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Fujifilm’s body to include Farhadi’s lumen. Such a modification provides an efficient means for supplying fluid to the balloon as is known in the art.
Regarding Claim 14, Fujifilm as modified discloses wherein the airtight valve unit is separably formed from the multi-lumen tube and is connected to a proximal end of the multi-lumen tube (the valve unit 62 is made as a balloon, which is separate from the tube body; see Fig. 7 showing the unit at the proximal end of the tube body). The Examiner notes that this claim also appears to be a product-by-process claim in that the unit is separably formed from and connected to the tube. The Examiner notes that the product (the valve unit) does not have a different structure based on the claim language. How it was formed does not change its structure. Even if it did, making something that has different properties separably would be obvious as that thing is different. Here, the valve unit is an expandable balloon and the multi-lumen tube is a thicker, more rigid component. Forming the balloon by taking some thin sheet of polymer material and connecting it to the tube is how things like balloon catheters are made. Finally, because removing components in this context would allow for them to be separately replaced or sterilized, there is a reason to make the proximal valve unit separable. See MPEP 2144.04.V.C citing In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Fujifilm to have a separably formed valve unit for the reasons stated above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fujifilm (JP2011-10950) in view of University of Kagawa (JP2013-244192; hereinafter “Kagawa”), Yamamoto (JP 2005-168990) and Farhadi (US 2015/0105621).
Fujifilm discloses the invention substantially as claimed as stated above.
Regarding Claim 13, Fujifilm does not explicitly disclose a distal balloon that is arranged distally of the tube body and that can expand and contract in a radial direction; a plurality of support members arranged on each outer peripheral portion of the fixing balloon and the distal balloon, extending between the fixing balloon and the distal balloon and capable of supporting an inner wall of a lumen; and an air supply tube that forms a flow path for sending the gas to the distal balloon, wherein the air supply device sends the gas to the air-supply lumen and the flow path formed by the air supply tube.
Kagawa teaches using multiple balloons having supports (23) that extend between the balloons. Yamamoto teaches using a tube or support member between balloons for supplying air (see tube 82). The Examiner also notes that because Kagawa’s supports 23 are connected to each balloon, using the supports as fluid supply tubes provides a simple means for inflating the balloons without adding additional components. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Fujifilm’s device to include Kagawa’s balloons with supports and air supply as taught by Yamamoto. Such a modification is known in the art for a variety of reasons. Using multiple balloons can help secure the device at a particular location and create a chamber or can be used as a means to help advance an endoscope through a lumen in the body.
Fujifilm also does not explicitly disclose wherein the tube body is a multi-lumen body where each of the main lumen and the air-supply lumen extend parallel to each other and to a longitudinal axis of the multi-lumen tube body. Farhadi teaches a multi-lumen body with a main lumen and air supply lumen that run parallel to each other (see Fig. 12 showing main lumen with 91 inserted therein and air supply lumen 23). The Examiner also notes that a standard catheter with a balloon is known to have a central lumen and a fluid supply lumen for the balloon. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Fujifilm’s body to include Farhadi’s lumen. Such a modification provides an efficient means for supplying fluid to the balloon as is known in the art.
Allowable Subject Matter
Claims 15-20 are allowed.
Claims 5-12 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.
The substantive reasons for allowance were set forth in the Office Action dated November 3, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Claim 13 is no longer rejected under 112b in light of the amendments.
The Examiner notes that “biasing material” and “movable mass” do not invoke 112(f).
Claim 1 is rejected as set forth above. The inclusion of a parallel lumen for inflation is disclosed in the prior art, and the Examiner considers this feature common in medical balloon devices.
The application is not in condition for allowance at this time.
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.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795