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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Response to Amendment
The amendment filed 02/09/2026 has been entered. Claim 1 has been amended. Claims 2-6 are cancelled. Claims 1 and 7 remain pending in this application.
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 the same combination of references for any teaching or matter specifically challenged in the argument. Claim 1 has been amended to recite that the first portion of the anal passage cap is connected with the stopper at a right angle. A new grounds of rejection is made over Isham in view of Karmazyn which make obvious the first portion of the anal passage cap connected with the stopper at a right angle.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isham (Pub. No.: US 2016/0184559 A1) in view of Karmazyn et al. (Pub. No.: US 2014/0296832 A1).
Regarding claim 1, Isham discloses (fig. 1-2, 7) a rectum expanding balloon catheter (rectal balloon apparatus 10) comprising:
A catheter body (shaft 12) comprising:
A rectum insertion part (end 16) configured to be inserted into a rectum (2) (fig. 7, ¶ 0059);
A gripping part extending from the rectum insertion part in a lengthwise direction of the rectum insertion part and configured to be used to insert the rectum insertion part into the rectum (see end of shaft 12 opposite end 16, fig. 1, ¶ 0074); and
A fluid flow passage (fluid passageway 64) positioned in an interior of the catheter body (fig. 7), and configured to pass a fluid (¶ 0071);
A balloon (14) configured to expand and contract an area on an outside of the rectum insertion part (¶ 0057) and configured to locate the rectum insertion part in the rectum (fig. 7);
An anal passage cap (locking device 13) movably coupled to the outer periphery of the catheter body (¶ 0071), and configured to be attached and detached to and from the anal passage (fig. 7, ¶ 0077),
Wherein the anal passage cap is coupled to the catheter body to be slid while generating sliding frictional forces (fig. 1-2, ¶ 0071);
Wherein the anal passage cap comprises:
A first portion (locking member 38) having a second cylinder shape having a second diameter (fig. 7-7A); and
A second portion (positioning member 18);
Wherein a first sidewall of the first portion and the second portion are connected with an angle (fig. 7A); and
A plurality of gradations (indicia 34) provided in the gripping part at a specific interval along the lengthwise direction of the catheter body (¶ 0059, fig. 1) and configured to indicate the length, by which the catheter body is inserted into the rectum (¶ 0059, fig. 7),
Wherein the balloon has different expansion coefficients (¶ 0068) such that an area of the balloon is expanded to be flat along the lengthwise direction of the catheter body (flat surface 15, fig. 2, ¶ 0060) in correspondence to irradiation of radiations (¶ 0074), and the remaining areas thereof are expanded to have a circular cross-sectional shape (fig. 2).
Isham fails to disclose a stopper removably coupled to an outer periphery of the catheter body, and configured to be adhered to a periphery of an anal passage and to restrict a length, by which the catheter body is inserted into the rectum; wherein the anal passage cap is attached to one side of the stopper; wherein one side of the stopper is configured to face the rectum, wherein the stopper is coupled to the catheter body to be slid while generating sliding forces, wherein the stopper has a first cylinder having a first diameter, the second diameter being smaller than the first diameter, and wherein a stepped portion is formed at a portion of the first portion which is connected with the stopper, and at the stepped portion, the first portion of the anal passage cap is connected with the stopper at a right angle.
Karmazyn teaches (fig. 1) a rectum expanding balloon catheter (10, abstract) and thus in the same field of endeavor, comprising;
A catheter body (34);
A stopper (disc 42) movably coupled to an outer periphery of the catheter body (¶ 0010), and configured to be adhered to a periphery of an anal passage and to restrict a length, by which the catheter body is inserted into the rectum (¶ 0010);
An anal passage cap (conical plug 30) attached to one side of the stopper (fig. 1), wherein the one side of the stopper is configured to face the rectum (¶ 0010),
Wherein the stopper is coupled to the catheter body to be slid while generating sliding forces (¶ 0010),
Wherein the stopper has a first cylinder shape having a first diameter (fig. 1, ¶ 0010);
Wherein the stopper is configured to remain external to the patient’s body in in order to be gripped to maintain control of the anal passage cap as well as provide a surface for adhesive to hold the anal passage cap in place (¶ 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Isham such that it comprises the stopper of Karmazyn, in order to allow for the position of the anal passage cap to be controlled external to the patient’s body as well as provide a surface for adhesive to hold the anal passage cap in place (Karmazyn ¶ 0010).
Further, such modification of Isham in view of Karmazyn such that the catheter of Isham comprises the stopper of Karmazyn results in the second diameter being smaller than the first diameter as the first diameter is configured to be external to the patient’s body (Karmazyn, ¶ 0010) and a stepped portion formed at a portion of the first portion which is connected with the stopper, and at the stepped portion, the first portion of the anal passage cap is connected with the stopper at a right angle (Isham fig.7A-7, Karmazyn fig. 1).
Isham fails to disclose that the second portion has a truncated cone shape.
Karmazyn teaches (fig. 1) the anal passage cap having a truncated cone shape (¶ 0010, fig. 1) configured to be inserted into the anus in order to prevent leakage and improve sealing at the anus (¶ 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second portion of Isham such that it has a truncated cone shape, as taught by Karmazyn, as such shape can be inserted into the anus in order to prevent leakage and improve sealing at the anus (Karmazyn ¶ 0010).
Changes in shape are a matter of design choice which a person of ordinary skill in the art would have found obvious (In re Dailey, 149 USPQ 47, see MPEP § 2144.04 IV. B.) as the applicant has not demonstrated the criticality of this limitation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Isham in view of Karmazyn, as applied to claim 1 above, and further in view of Horvers (Pub. No.: US 2012/0232640 A1).
Regarding claim 7, Isham in view of Karmazyn fail to disclose wherein the balloon includes a rubber or silicon material that is expanded and contracted.
Horvers teaches (fig. 1) a rectum expanding balloon catheter (catheter 100, which can be inserted into the rectum ¶ 0115) and thus in the same field of endeavor, comprising: a balloon (4), wherein the balloon includes a rubber or silicon material (¶ 0107) that is expanded and contracted (¶ 0114), wherein rubber or silicon are biocompatible materials (¶ 0107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Isham in view of Karmazyn such that it includes a rubber or silicon material, as taught by Horvers, as such material is biocompatible (Horvers ¶ 0107).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bjerregaard et al. (Pub. No.: US 2019/0275232 A1) discloses an anal passage cap having a truncated cone shape. Beechie (Pub. No.: US 2010/0249730 A1) discloses an anal passage cap having a truncated cone shape.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781