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 Arguments
Applicant's arguments filed April 22, 2026 have been fully considered but they are not persuasive in view of the new grounds of amendments set forth below addressing the claims.
In response to applicant’s argument that Bosel does not disclose the capsule-shaped portion has a constant diameter that is larger than a diameter of all other portions of the tube, the examiner disagrees. Balloon 18 of Bosel shows a capsule-shaped portion has a section with a constant diameter that is larger than a diameter of all other portions of the tube (figure 2) and therefore applicant’s arguments are not persuasive. Similarly, Fujikura also discloses balloon 42 comprises a cylindrical shape and thus would have a section with a constant diameter larger than a diameter of all other portions of the tube (figure 2), and therefore applicant’s arguments with respect to Fujikura are also not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31-47 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 31 recites the limitation “the capsule-shaped portion having a constant diameter larger than a diameter of all other portions of the tube” in the amendments to the claims. The specification does not disclose this limitation. The specification merely discloses that the capsule-shaped portion can be a cylinder having hemispherical ends. Therefore, the hemispherical ends would not have a constant diameter with the cylinder portion and thus the limitation is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention and introduces new matter into the claims.
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 31, 32, 34, 37, 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujikura (US 7678044).
Regarding claim 31, Fujikura discloses a dilator comprising: a tube (48) comprising a proximal end, a distal end, and a central lumen therethrough (figure 3), the proximal end comprising a connector configured to connect to an inflation device (130 via 122b); and a balloon (72) disposed between the proximal end and the distal end of the tube, the balloon configured to transition between a contracted state and an expanded state, wherein the dilator is insertable into a body passage of a subject in need thereof, and wherein the distal end of the tube comprises a capsule-shaped portion (42) that is sized for insertion in the body passage, the capsule-shaped portion (42) having a constant diameter (cylindrical shape, cylinders have a length with a constant diameter) larger than a diameter of all other portions of the tube (figure 1, 2),.
Regarding claim 32, Fujikura discloses all of the limitations set forth in claim 31, wherein the body passage is a gastrointestinal passage, and wherein the gastrointestinal passage is an esophagus, pylorus, duodenum, or any combination thereof (device can be inserted into alimentary canal and therefore is capable of being insertable into esophagus, pylorus, duodenum or any combination thereof).
Regarding claim 34, Fujikura discloses all of the limitations set forth in claim 31, further comprising the inflation device, wherein the inflation device is a pump or a syringe (130, pump, C:6, L:15-24).
Regarding claim 37, Fujikura discloses all of the limitations set forth in claim 31, wherein the capsule-shaped portion is removably attached to the distal end of the tube (figure 1, 42 is removed from distal end of tube 70).
Regarding claim 46, Fujikura discloses all of the limitations set forth in claim 31, wherein the balloon is in fluid communication with the central lumen of the tube (figure 3, 112b).
Regarding claim 47, Fujikura discloses all of the limitations set forth in claim 31, wherein a portion of the tube defines one or more openings, and wherein the balloon is disposed around the one or more openings (figure 3, opening at distal end of lumen 112b).
Claims 31, 38, 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosel (US 20120180787).
Regarding claim 31, Bosel discloses a dilator comprising: a tube (17) comprising a proximal end, a distal end, and a central lumen therethrough (figure 1), the proximal end comprising a connector (at connector P) configured to connect to an inflation device (36); and a balloon (24) disposed between the proximal end and the distal end of the tube, the balloon configured to transition between a contracted state and an expanded state, wherein the dilator is insertable into a body passage of a subject in need thereof, and wherein the distal end of the tube comprises a capsule-shaped portion (18) that is sized for insertion in the body passage.
Regarding claim 38, Bosel discloses all of the limitations set forth in claim 31, wherein the capsule-shaped portion (18) is integrally formed with the distal end of the tube (figure 1).
Regarding claim 39, Bosel discloses all of the limitations set forth in claim 31, wherein the capsule-shaped portion has an outer diameter of about 1 mm to about 15 mm (paragraph 0029, the limitation ‘about 15mm’ is sufficiently broad to encompass 16mm).
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 (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 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.
Claims 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Fujikura (US 7678044) as applied to claim 31 above, and further in view of Hopkinson et al (US 20190314619).
Regarding claim 33, Fujikura discloses all of the limitations set forth in claim 31, but does not specifically disclose the balloon has a pressure between about 3 atmospheres to about 30 atmospheres when in an expanded configuration. Hopkinson et al (hereafter Hopkinson) teaches it was known in the art at the time of the invention for balloon dilation systems to be used with endoscopes to be inflated or expanded to discrete diameters with pressures ranging from about one to about 2 to about 13atm (paragraph 0024-0025), such that the practitioner may stop balloon expansion at any stage dependent on the condition of the tissue being dilated. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the balloon have a pressure between about 3atm to about 30atm when in an expanded configuration, as taught as a known atm for dilation balloons in the art at the time of the invention, in order for the practitioner to stop balloon expansion at any stage dependent on the condition of the tissue being dilated, 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 claim 35, Fujikura discloses all of the limitations set forth in claim 31, but does not disclose the inflation device comprises a pressure gauge. Hopkinson et al (hereafter Hopkinson) teaches it was known in the art at the time of the invention for balloon dilation systems to be used with endoscopes have a pressure gauge associated with the inflation device to measure pressure inside the balloon (paragraph 0035), such that a practitioner may stop balloon expansion at any state dependent upon the condition of the tissue being dilated (paragraph 0025).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Fujikura (US 7678044), as applied to claim 31 above, and further in view of Kaiser et al (US 20140066939).
Regarding claim 36, Fujikura discloses all of the limitations set forth in claim 31, but does not disclose a relief valve configured to prevent over-pressurization. However, Kaiser et al (hereafter Kaiser) teaches it was known in the art at the time of the invention to include relief valves in balloon catheters to avoid damage to the patient’s tissue or to reduce the rise of inadvertent balloon rupture. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include a relief valve configured to prevent over-pressurization on the balloon of Fujikura, as taught as known in the art by Kaiser, in order to avoid damage to the patient’s tissue or to reduce the rise of inadvertent balloon rupture.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Fujikura (US 7678044), as applied to claim 31 above, and further in view of Saito (US 20090187207).
Regarding claim 40, Fujikura discloses all of the limitations set forth in claim 31, but does not disclose the capsule-shaped portion has an outer diameter of about 3 mm. However, Saito teaches it was known in the art at the time of the invention to have a balloon dilator used with an endoscope to have a portion with an outer diameter in the range of 3.7-3.75mm to allow it to smoothly draw the rest of the inflatable portion into the channel. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make an outer diameter of the capsule-shaped portion of Fujikura have an outer diameter of about 3mm, as taught as known in the art at the time of the invention by Saito, in order to smoothly draw the capsule-shaped portion back into the tube.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Fujikura (US 7678044), as applied to claim 31 above, and further in view of Condon (US 5188596).
Regarding claim 41, Fujikura discloses all of the limitations set forth in claim 31, but does not disclose a camera secured to the distal end of the tube. However, Condon et al (hereafter Condon) teaches it was known in the art at the time of the invention for a dilation balloon and scope to comprise a video camera at a distal end of a tube (20) of a balloon dilator with appropriate lenses to convert the image at the distal end to a video signal to display on a video monitor (C:5, L:20-36) in order to visualize the area outside the catheter in order to determine whether the dilation balloon and fixation balloon are properly located within their respective targets. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include a camera secured to the distal end of the tube, as taught by Condon, in order to visualize the area outside the catheter in order to determine whether the dilation balloon and fixation balloon are properly located within their respective targets.
Claims 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Fujikura (US 7678044), as applied to claim 41 above, and further in view of Bayer et al (US 20080033450).
Regarding claim 42-45, Fujikura in view of Condon teaches all of the limitations set forth in claim 41, wherein the camera comprises appropriate lenses to convert the image at the distal end (C:5, L:19-31), but does not teach the camera is capsule-shaped and two or more lenses each facing a different direction. Bayer et al (hereafter Bayer) discloses a tubular device comprising a camera capsule with imaging lenses facing different directions to provide additional viewpoints, wherein the camera comprises one or more internal electronic components configured to process or manipulate data acquired by the camera and one or more illumination sources, and wherein the camera is removably attached to the tube (paragraph 0065, 0088) in order to visualize the anatomical site. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include the capsule-shaped camera with imaging lenses facing different directions of Bayer onto the device of Fujikura in view of Condon, in order to provide multiple viewpoints the anatomical site during a procedure.
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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