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 .
Disposition of Claims
Claims 1-20 are pending.
Claims 7-20 are withdrawn.
Response to Amendment
The amendment filed on 7/31/2026 has been entered. Applicant’s amendments to the Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 5/13/2026.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 7/31/2026, with respect to the interpretation of “a cutting device” in claim 15 have been fully considered and are persuasive. The claim interpretation of claim 15 involved under 35 USC § 112(f) has been withdrawn.
Applicant’s arguments, see pages 9-10, filed 7/31/2026, with respect to the rejection under 35 USC § 102 of Claim 1, have been fully considered and are not persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims; however, a new ground of rejection is not necessitated.
The applicant argues that the amended claims overcome the current grounds of rejection. The applicant’s argument is on the grounds that Ouchi fails to disclose “wherein the protrusion … is configured to flatten a surface of the engaged tissue.” Examiner respectfully disagrees. Ouchi discloses a cap with the same structural arrangement as the claimed invention (Fig. 1-2). When prior art structure is the same as, or substantially identical to, the claimed structure, the claimed functional characteristics are inherent in the prior art structure. See MPEP §2112.01. Accordingly, since Ouchi discloses a cap with a protrusion having the same structure and configuration as recited in the claims, Ouchi’s device necessarily possesses the claimed function of flattening a surface of the engaged tissue.
Please see section 35 U.S.C. § 102 below for further explanation
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the engaged tissue" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the engaged tissue” is being interpreted as “the tissue engaged by the protrusion.”
Claim 2-6 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2002/0035311 A1 to Ouchi (“Ouchi”).
Regarding claim 1, Ouchi discloses a cap (tip hood 10; Fig. 1, paragraph 0022) for a flexible elongate member insertable into a body (Fig. 1 shows the tip portion of an endoscope according to a first embodiment of the invention. It comprises an insertion portion 1 in a flexible tubular form that is fitted with a cylindrical tip body 2 at the distal end; Fig. 1, paragraph 0018), comprising:
a proximal end configured to couple with the flexible elongate member (indicated by 10a is a circumferential projection that is formed on the inner periphery of the tip hood 10 at the rear end in such a way that it deforms elastically to come into or out of engagement with a groove formed in the outer periphery of the tip body 2; Fig. 1, paragraph 0023);
a distal end defining a first inner diameter (distal end of the tip hood 10 is opposite the rear end and has a first inner diameter; Fig. 1);
a lumen extending between the proximal end and the distal end (the tip hood 10 is a cylindrical member; Fig. 1, paragraph 0022); and
a protrusion located between the proximal end and the distal end (in the intermediate position of the tip hood which is between the distal end face of the tip body 2 corresponding to the bottom plane of the tip hood 10 and its distal end, an aspirated mucosa moving regulating portion 11 is formed; Fig. 1, paragraph 0024) and defining a second inner diameter that is smaller than the first inner diameter (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025),
wherein the protrusion is configured to engage tissue received in the lumen through the distal end (the sucked portion of the mucosa becomes like a “polyp” in shape but its projecting end contacts the aspirated mucosa movement regulating portion 11, it will not be further aspirated into the tip hood 10 but maintains a certain distance from the viewing window 3; Fig. 2, paragraph 0026-0027) and is configured to flatten a surface of the engaged tissue (Fig. 2). Because the aspirated mucosa movement regulating portion has the same configuration and relative arrangement as the claimed protrusion, the cap of Ouchi necessarily performs the same function. Specifically, when the protrusion engages the tissue, the flat distal surface inherently flattens the surface of the engaged tissue.
Regarding claim 2, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion is spaced distally apart from a distal end of the flexible elongate member when the proximal end is coupled with the flexible elongate member (in the intermediate position of the tip hood which is between the distal end face of the tip body 2 corresponding to the bottom plane of the tip hood 10 and its distal end, an aspirated mucosa moving regulating portion 11 is formed in order to ensure that the mucosa aspirated from the distal end of the tip hood 10 toward the aspiration port 5 will not get to the viewing window 3; Fig. 1, paragraph 0024), and has a flat distal surface configured to form a flat target surface on the tissue engaged by the protrusion (the aspirated mucosa movement regulating portion 11 has a flat distal surface; Fig. 1). Because the aspirated mucosa movement regulating portion has the same configuration and relative arrangement as the claimed flat distal surface of the protrusion, the cap of Ouchi necessarily performs the same function. Specifically, the protrusion engages the tissue, the flat distal surface inherently flattens the engaged tissue to form a flat targe surface.
Regarding claim 3, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion extends circumferentially around the lumen (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025).
Regarding claim 5, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion defines a circular end of the lumen (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025).
Regarding claim 6, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the distal end is made from a substantially transparent material (the tip hood 10 is a cylindrical member formed typically of an elastic transparent material; Fig. 1, paragraph 0022).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ouchi.
Regarding claim 4, Ouchi discloses the cap according to claim 1. However, Ouchi does not disclose wherein the protrusion defines a non-circular end of the lumen. Ouchi does not disclose a protrusion defining a non-circular end of the lumen such as an oval end of the lumen, but Ouchi does disclose said protrusion defining a circular end of the lumen. It is noted, that there is no significant difference between a circular and oval shape, as both shapes have continuously curved, closed perimeters without corner or edges. Further, oval shaped lumens were well known in the art at the time the invention was made. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cap of Ouchi to have a non-circular end of the lumen, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
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 OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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